Very stable operation with over 70 years of injection molding expertise is seeking a driven QA Manager to join their manufacturing team. The qualified candidate will report to the Business Unit Manager and be responsible to plan, coordinate, and direct quality control programs.Responsibilities: Create and implement inspection criteria and procedures. Provide necessary inspection activities for each product throughout production cycle. Apply total quality management tools and approaches utilizing analytical and reporting processes as appropriate within each department. Direct workers engaged in inspection and testing activities to ensure continuous control over materials, inspection equipment, and products. Work with suppliers to ensure the quality of all purchased parts for company use. Play active role on quality management teams within organization and prepares and conducts Quarterly Management review meetings. Design and implement quality control training programs for key personnel in conjunction with managers. Investigate and resolve any customer complaints regarding quality. Lead in facilitating Customer, ISO, and FDA Audits. Provide, in conjunction with MRB activities, the disposition of parts for acceptance or rejection. Ensure finished products are monitored for conformance to customer requirements. Ensure that measurement and test equipment is calibrated per required schedule Ensure that a quality system is established, implemented, and maintained in accordance with ISO 9001. Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product. Requirements: High School Diploma and at least 8 years of Quality Assurance experience or equivalent in an Injection Molding or Job Shop environment. BA or BS Degree strongly preferred Proficient with Microsoft Office (Word, Excel), and working knowledge of statistical (SPC) programs. Must be able to use micrometers, vernier/dial calipers, and other basic measuring tools Must be familiar with the use and operation of optical comparators and co-ordinate-measuring machines (basic CMM programming a plus). Strong knowledge of PPAP Requirements desired. Experience with GD&T/True positioning/Blueprint reading. Demonstrated experience with 8D/5 Why processes. ISO Auditor Certification or Auditing Experience. Familiarity with ISO9001, FDA/GMPs, and ITAR programs

Genabio Diagnostics is a Bedford-based In-vitro Diagnostic company. At Genabio Diagnostics, we develop and commercialize low-cost, easy-to-use, and high-quality testing for over-the-counter, point-of-care and laboratory testing.As a growing company, we offer an environment that is both fast paced and collaborative. At Genabio you will have the opportunity to work alongside driven people to develop your skills and career. You will be exposed to experts at our Bedford, MA office, from design to marketing. All team members are easily accessible, and communications are open, friendly, and productive.If you are interested in leaving your mark in this rapidly growing field of over-the-counter diagnostics, consider applying to Genabio today.The primary responsibility of this position is to support the R&D, manufacturing, sales, and marketing teams during from design and development through manufacture, distribution, and sales to End of Product Life.Essential Responsibilities and Accountabilities:Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and regulations.Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.Responsible for driving quality programs, continuous improvement projects, and CAPA investigations and solutions to ensure appropriate measures are implemented to prevent recurrenceLeads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of audits.Supports the NCMR programs and ensures appropriate disposition of nonconforming partsSupports all departments to ensure a timely root cause identification for process/product deviationsUtilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques: experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.Review device history records and release of productsSupport new product introductions, qualification of new suppliers, development and approval of new product documentation.Develop and maintain documentation in compliance with FDA, ISO, MDR, IVDR requirementsImplement and perform post-market surveillanceOther duties as assignedQualifications:Knowledge of Quality system principles; FDA Quality System Regulation (cGMP); 21CFR820, ISO 13485 Quality system standards for medical device, IS017971 Risk Management Systems is preferred.Knowledge of inspection methods and sampling plans for in vitro diagnostic products, statistical analysis, and the application of Six Sigma, Kaizen, and Lean Manufacturing techniques is desired.Experience in FDA regulated environment preferred.ASQ Certification Preferred.Skills and Competencies:Strong organization and communication skills.Excellent team player with strong interpersonal skills.Comfortable working in a fast-paced environment while keeping to tight deadlines.Proficiency with Microsoft Office Tools.Exposure to Statistical software is preferred but not required.Knowing Chinese is a plus.Education/Experience:Bachelor’s degree in Science, Engineering, or a related field.Experience in the medical device industry or related field is preferred.

JOB TITLE: Senior QA (Manual testing mostly)Location: BOSTON, MAThis position requires onsite in Boston 3 days per/week; Tues-Thurs and no exceptions will be made. POSITION SUMMARY:Must have prior working experience within Investment Management or Asset ManagementSkilled in manual software testing techniquesMust be versed with SQL and testing dataAny experience with API testing and related testing tools is a plus

***MUST BE LOCATED IN MASSACHUSETTS******MUST BE WILLING TO GO ONSITE IN QUINCY, MA***Insight Global is sourcing for a Quality Assurance Analyst for the Commonwealth of Massachusetts. This individual would be joining the Health and Human Services organization under the Medicaid Systems Development team and will be supporting the Health Safety Net (HSN) application. This application pays acute care hospitals/community health centers for certain essential health care services provided to qualified uninsured and underinsured Massachusetts residents. As a Sr. Quality Assurance Analyst, the individual will mainly assist in managing the testing activities for the HSN application. This individual should be well-versed in conducting requirement analyses, designing, and developing test cases and executing test cases through manual and automated methods. The Sr. Quality Assurance Analyst should have experience with capturing defects in the tracking system, developing day-to-day metric reporting, and providing support for the test manager while also ensuring well-defined requirement to contribute to defined functional use cases. The team is looking for an individual who has strong verbal, written, and presentation skills as well as someone who is highly analytical and confident in their abilities to independently analyze test results and make recommendations.Must Haves:5+ years of experience as a QA AnalystStrong automation experience, along with experience on the manual sideExperience with SeleniumPortrays strong analytical knowledgeObtains experience with QA tools: Jira, Microsoft office tools (SharePoint)API Testing and GUI Testing experienceKnowledge of Application Lifecycle Management Plusses:Prior experience in healthcare/government setting

DPS Engineering is looking for a Quality Assurance Specialist for support and oversight of Internal QA Operations for manufacturing mRNA-based drug products. The individual in this role will be part of a cohesive team responsible for rapidly releasing cGMP mRNA-based drug products. S/he will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in clinical and/or commercial products. This individual will work closely with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Digital and Manufacturing Science and Technology counterparts.Responsibilities:Oversee and review executed electronic and paper batch record documentation.Author and review SOPs, policies, and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.Closely partner with peers for rapid review of batch-related documentation.Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.Monitor process operations to ensure compliance with specifications.Assist in the investigation of procedural deviations.Oversees execution of CAPAs, deviations, and change controls in support of PCV manufacturing.Reviews minor manufacturing deviations.Develop batch records, SOPs, and training materials as needed.Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.Utilize knowledge to improve operational efficiency.Participate in quality oversight of manufacturing through real-time observations of activities.Skills & EducationAt least 2-3 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry, or related field.Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLPAbility to collaborate fluidly with peers, supervisors, and cross-functional support groups requiredExceptional written, oral communication and organizational skills requiredMust be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.Effective verbal and written communication skills.Excellent interpersonal, teamwork, and leadership skills are required.Participates in determining objectives of assignment and plans, schedules, and arranges own activities in accomplishing milestone achievements.

Now hiring a Quality Assurance Analyst in Boston, MA!Trillium Technical is looking for a Quality Assurance Analyst!QA Analysts should have a working knowledge of the Waterfall, Iterative Development as well as Agile/Scrum methodologies to immediately work on current projects. QA Analyst should be able to negotiate between Waterfall, Iterative and Agile testing methodologies as needed. Job Responsibilities:•Define the testing objectives•Define the scope of the testing effort•Define the testing approach•Identify and meet the key milestone dates•Organize the testing effort and lead team members (when needed)•Define testing roles and responsibilities within the team (when needed)•Define testing documentation•Define the business processes to be tested•Identify the systems functionality to be tested•Identify the systems interfaces to be tested•Write detailed QA Test Plans and detailed test scenario scripts. •Create data required for positive, negative and regression testing•Write and maintain defect /Issues Log •Create testing progress reports •Create and maintain a Testing Results Matrix to determine if all functional/business requirements have been tested•Test all Functional/Business Requirements•Test multiple components or applications to ensure the integrity of data and functionality among these separate components •Test system/application navigation •Evaluate overall performance (when needed)•Re-test fixes and update Bug/Issues Log and Testing Results Matrix•Perform Regression testing to discover any adverse effects on other functionalities•Perform Stress testing and Load testing (when needed)•Be familiar with Usability and Accessibility testing objectives •Assist during User Acceptance testing •Assist the Training Department •Assist with post-production implementation testing•Working knowledge of Waterfall, Iterative and Agile/Scrum methodologies •Knowledge of Microsoft Test Manager or similar testing tool.•Experience with automated testing.•Support the project in any way neededIf interested, please apply today!•Bachelor’s degree or equivalent.A minimum of 5 years’ experience in Software Quality Assurance Testing.•Familiar with and Agile, Iterative Development or Waterfall Methodologies.•Knowledge of Windows, Web based and MS Access applications.•A minimum of one year experience with Salesforce platform application testing•Knowledge of Service Now platform is a plus.•Experience with Data/Messaging Exchange between systems.•Basic understanding of SQL and Database Management.•Proficient with Azure Dev Ops (ADO) and working knowledge of Industry Tool Sets, such as: Defect Management Applications, Modeling, and automated testing tools (Selenium, Cucumber).•Knowledge of the Software Development Lifecycle with an emphasis on Software Test Procedures, Techniques and Best Practices.•Excellent verbal and written communication skills, with an ability to interact in a collaborative environment with all project members and stakeholders.•Ability to perform and achieve objectives in a fast-paced environment.•QA Certification or Salesforce Certification is a plus.By applying to this job, I agree to receive electronic communications including SMS text and email regarding future opportunities, referral bonus incentives, and other promotions from Trillium. You may opt out at any time from future communications by responding STOP to any electronic communication. You may view our full privacy policy at https://trilliumstaffing.com/jobs/privacy/. #CBPRO

Role OverviewOur client, a rapidly expanding intravascular medical device company, is currently recruiting a Senior Quality Assurance Engineer who will infuse the Quality Assurance Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a fast-paced start-up culture that is known for its innovative and growth-oriented vision. Responsibilities include:Provide design quality engineering leadership to cross-functional product teams, including new product development, sustaining manufacturing and engineering.Provide quality improvement initiatives related to in-processes manufacturing.Participate in the design control and review processes, including quality planning.Actively participate in risk management, dFMEAs, pFMEAs, troubleshooting and root cause analysis for new and existing products.Ensures CAPA/SCARS are implemented effectively and results in timely analysis of root cause initiatives and improvements for product and process issues.Manages the complaint process.Participate in design and manufacturing quality related issues.Lead supplier quality, including audits and supplier issues.Participate as quality lead in the product reliability team meetings.Responsible for the review and approval of design verification and validation protocols and test reports.Review and approve of medical device software verification and validation.Perform quality driven statistical analysis.Critical RequirementsAppropriate full-time work experience is mandatory (6+ Years Experience in the Medical Device industry preferred)Design experienceFor the right individual, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.Compensation And Other DetailsBase Salary: Highly competitive package, with added benefits.

Ref ID: 02130-0012604307Classification: Manager of Quality AssuranceCompensation: $165000.00 to $175000.00 yearlyIf you are energized by building elegant solutions to real-world QA problems, enjoy working in the (AWS) cloud, and want to be part of a great team, this is the role for you! The ideal candidate will have strong analytical abilities, experience working with complex, real-world data sets in a healthcare environment, demonstrated managerial and technical judgment, intellectual curiosity, and solid written and verbal communication skills. He/she will have a strong bias toward data-driven decision making. The Senior Manager will: • Work together with the Vice President, Software Engineering and the Senior Manager, Data Engineering, and the software development team to effectively leverage a contemporary QA pipeline. • Make buy vs. build decisions relative to QA automation tools and frameworks. • Promote and document best practices relative to QA automation. • Actively participate in the design and development process, ensuring software and systems are testable. • Drive best practices for continuous improvements across multiple teams using metrics, operational data, and feedback. • Partner with internal customer teams to understand customer experiences, pain points, and critical workflows - translate that data into evolving test plans. • Investigate latest QA testing modalities and practices, using this knowledge to maintain cutting-edge test strategies. • Partner with peers to assess/increase automated test coverage for all features. Note that this role has the potential of promotion to Director as commensurate with company growth and personal performance.

Now hiring a Senior Quality Assurance Analyst in Quincy!Trillium Technical is now seeking a Senior Quality Assurance Analyst for work in Quincy, MA!Job Duties: (Detailed list of Responsibilities):• As directed, provide oversight of day-over-day testing activity and support. • Participate in weekly meetings with the team as required.• Participate in the defect triage meetings, providing information about defects and route cause analysis.• Participate in defect remediation meetings to work on extended pending and warranty defects.• Participate in Joint Application Design (JAD) sessions involving cross-functional teams.• Develop and execute test cases and test scripts for end-to-end system testing. • Create and deliver test plans and test cases - create effective and reusable test scripts based on functional requirements and use cases. • Provide oversight, coordinate, and prepare test plans and scenarios within and outside the scope. • Performing requirements verification testing, functional testing, security testing, regression testing, positive and negative testing, and ADA testing.• Analyze test results and make confident decisions and recommendations.• Efficiently execute system and user acceptance testing, document all testing results, and ensure that defects are recorded and tracked.• Document all testing results and ensure defects are recorded and tracked.• Work with QA technical team during data setup for performance testing.• Perform a critical test results analysis, make confident decisions and recommendations, and adhere to escalation processes to ensure accountability and issue resolution. • Participate in scope review sessions with the business analyst (BA) and subject-matter expert (SME) teams. • Work with SQA Manager and across project teams to ensure testing completion meets project deadlines.• Work closely with the testing team and resolve testing-related issues/concerns.• Do the Gap analysis create new possible test scenarios and add them to the testbed• Develop test automation scripts and provide technical support.• Develop and maintain testing issue documentation and adhere to escalation processes to ensure accountability and issue resolution. • Technical skills in Oracle or SQL Server Development suites• IBM Test Manager, HP Load Runner, HP QTP, Jira, MS Office software.• Develop and distribute Test Summary Reports after each cycle.Apply now!• Broad knowledge of testing approaches and techniques for certifying software acceptance.• Demonstrated ability to work independently and in project teams, providing relevant quality assurance services to a broad audience.• Highly analytical and able to independently analyze test results and be confident in making decisions and recommendations.• Expertise in backend testing and writing SQL queries, including complex subqueries and joins.• Experience working with Oracle database.• Experience in Jira or similar products.• Experience working with HP Quality Center, IBM Clear Quest, IBM Test Manager, and MS Office software.• Experience in reviewing the work of business analysts and subject matter experts, ensuring well-defined requirements contribute to defined functional use cases.• Experienced in reviewing the work of business analysts to ensure well-defined requirements that contribute to defined functional use cases.• Strong analytical, troubleshooting, and problem-solving skills.• Strong verbal, written, and presentation skills.• Bachelor’s degree or higher in Computer Science or University degree or equivalent experience.• Five years of experience in black-box, white-box, functional, smoke, and regression testing.• Prior experience in healthcare or government setting desired.By applying to this job, I agree to receive electronic communications including SMS text and email regarding future opportunities, referral bonus incentives, and other promotions from Trillium. You may opt out at any time from future communications by responding STOP to any electronic communication. You may view our full privacy policy at https://trilliumstaffing.com/jobs/privacy/. #CBPRO

Title: Quality Assurance Manager  Location: Bedford MA (hybrid local)  Start date: ASAP Duration: 12 months CTH Hours: Mon-Fri 8-5pm Experience: - BS or higher - 5-10 years of experience in Gene Therapy or Biologics MUST HAVES: - Perform batch disposition of DS, DP, FDP, Plasmids, and Clinical Kits for externally manufactured products -Identify, track and resolve quality related issues in a timely manner and ensure regulatory and HMI procedural requirements are met -Master Batch record review and approval -Review and approval of Quality Control activities including testing, method qualification/validation, and stability protocols/reports -QA review of quality system records including: Deviation, CAPA, Change Control, OOS, Product Complaints and Investigations -Supports regulatory inspections and external partner audits as needed -Vendor Change Control reviews, assessments and tracking - Tracking and trending of quality metrics with SmartSheets Database/Dashboards (nice to have)

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.Your Work Matters.At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the communityWe’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job OverviewAbout the Company Snapdragon Chemistry, Inc. is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where synthetic chemistry underpins product development.   In 2021 Snapdragon will commission a new 51,000 SF GMP manufacturing facility, enabling us to deliver GMP drug substances to our clients from the Waltham facility. We rely on our most valuable resource – our people – to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in flow chemistry and product development while also cultivating and furthering your career.  At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture. Job Description Snapdragon Chemistry is currently seeking exceptional candidates for its Quality Assurance Associate Director / Director position – level to be determined based on experience.  A successful candidate will be joining a highly innovative and entrepreneurial team of engineers and scientists seeking to advance pharmaceutical development and manufacturing.We are looking for candidates who have a passion for the science of pharmaceutical manufacturing and excited to share the Snapdragon vision of future manufacturing.  The ideal candidate will have at minimum a BS degree in scientific discipline and 7-10 years quality assurance experience.     ResponsibilitiesResponsibilities Plan, coordinate, and direct quality assurance (QA) GMP activities in multi-product GMP facility to ensure consistent high-quality product manufacturing Working with QA staff to manage day-to-day QA activities for final disposition of products  Write, review, revise, approve SOPs, MBR, etc Work closely with Facilities, CMC and Quality Control functions to manage Client site audits   Manage quality technical agreements and quality questionnaires Manage Supplier and Vendor qualifications Responsible for internal audits, observations and responses  Oversee training program. Conduct GMP training sessions  Manage Quality Metrics to provide snapshot of status of QMS within Snapdragon  Develop quality assurance plans by conducting risk assessments Responsible for ensuring Snapdragon products and services meet client and industry standards of quality Qualifications/SkillsQualifications BS degree in scientific discipline 7–10 years industry QA experience including managing GMP quality systems in the Pharma/Biotech industry Extensive knowledge of cGMP and ICH requirements for small molecule development and manufacturing, including drafting, interpreting, and implementing quality assurance policies and procedures as well as establishing document management activities Significant experience with establishing QMS solutions (especially for a multi-client environment), supporting on-site audits, and ensuring finished product quality Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions. Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives. Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines. Excellent communicator with strong leadership, presentation and influencing skills, and problem-solving ability. Experience in managing relationships with internal departments, external vendors, and clients in a collaborative manner. Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively. Education, Experience & Licensing RequirementsCambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Manager / Sr Manager Clinical Quality Assurance Suitable for: Clinical QA Auditor, Clinical Quality Associate, Clinical Quality Specialist, Clinical QA Manager and Senior Manager Clinical QA Are you looking to start a role with a world leading and innovative Clinical Biopharma company based in Massachusetts where you can grow your career? If so, get in touch as we are recruiting for a permanent Manager/Senior Manager of Clinical Quality Assurance.For this role, they are offering a highly competitive salary, hybrid working flexibility, excellent bonus and a comprehensive benefits package.Please contact Simba Nyakupinda at +1 (646) 582-3704 or by email at simba@peoplewithchemistry.com for more information about this exciting opportunityFor this exciting Clinical Quality Assurance Manager role, your main duties include, but are not to be restricted to, the following duties:Provide compliance support, including issue resolution, impact assessment, and inspection readinessProvides input to clinical functions to ensure clinical trial activities are conducted by CROs in compliance with GCP regulations and internal requirementsProvide internal audit support related to systems, documents, and functionsPrepare quality metrics for presentation to managementWork directly with CROs and other external suppliers and collaborators, managing the chain of communication-related to GCP complianceOwnership of all GCP QA responsibilities in the businessAssessing and improving current processesOverseeing and managing relations with CROs based in the USTo be successful in this role, your experience will need to include: 5 years + in Clinical Quality AssurancePrevious experience managing CROs and clinical suppliers requiredExperience from a sponsor company (pharma/biotech), CRO or GCP rolesPrevious experience with Veeva QualityDocs and ComplianceWireMEDICAL REQUIREMENTSCOVID-19 vaccine required to come on-site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach for an accommodationInterested in finding out more?The full job description is available post-application, please apply below. This role is being managed by Simba Nyakupinda at Meet, please contact me at +1 (646) 582-3704 or directly by email at simba@peoplewithchemistry.com to discuss this in confidence.

Location: Malden, MASalary: Based on skill and ExperienceDescription: Performance Standards Compliance Summary of the Job:  Responsible for developing, maintaining, updating, and improving the Food Safety and Quality Management System. Oversees and enforces compliance and remains current with all applicable regulatory and GFSI requirements, specifically the SQF Food Safety Code for Manufacturing and the SQF Food Quality Code. Develops and enhances the plant sanitation and new product development programs Position Reports To General Management Salary range: Upon seniority Work Schedule: Full Time Monday-Friday on-site Starting Date: Immediately Essential Duties include, but are not limited to: Schedule and oversee plant compliance with the Food Safety and Quality Management System through monitoring, verification, and validation activities. Ensure critical limits and food safety and quality controls remain current and effective. Remain current and ensure compliance with product labeling requirements. Ensure the plant is “audit-ready” and oversee customer, third-party, or regulatory audits. Evaluate non-conformities and deviations through root cause analysis and provide recommendations and guidance for resolution. Develop and oversee the plant’s microbiological testing program to ensure food safety, quality, and adequate sanitation practices. Oversee new product development from product concept through launch and implementation. Develop and deliver employee training related to the Food Safety and Quality Management System. Oversee the Sanitation Department and ensure adequate plant sanitation Experience/Education Required: A degree in food safety/science or a related field is preferred. 3 to 5 years of Food Safety and Quality Management experience. HACCP Certification and proficient knowledge of the SQF Code are mandatory. Knowledge of OSHA and National Fire Protection Association (NFPA) regulations. Knowledge of HACCP and GMP guidelines or equivalent. Strong interpersonal and communications skills involving a diverse workforce Physical Demands: Work Environment: Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  Contact: bhill01@judge.comThis job and many more are available through The Judge Group. Find us on the web at www.judge.com

REF: CO220 Quality & Patient Safety Specialist Nurse (RN required, MSN Preferred) Boston, MA The Quality Improvement Project Specialist RN plays a key role in ensuring that the hospital performs at the highest levels on standardized, national measures of clinical care quality in the Department of Surgery. He/She ensures the accurate and timely collection of data from clinical records, identifies opportunities for improvement, communicates and works collaboratively with multidisciplinary improvement teams, and facilitates the creation and implementation of improvements in care processes.ESSENTIAL RESPONSIBILITIES / DUTIES: Provide support to multidisciplinary teams in the development, implementation and evaluation of quality care initiatives for specific surgical patient populations.Participate in the development and implementation of data collection toolsEnsure accurate collection of data for selected, standardized measures of clinical qualityReview accuracy of data collected from clinical records and other sourcesEnter data retrieved from clinical and administrative systems into web-based programsWork effectively with colleagues internally and externally to ensure that deadlines are met for data submission to various internal and external stakeholders.Coordinates new and ongoing projects under the direction of the Director of Clinical Quality and Patient Safety.Define project scope, goals and deliverables that support Department of Surgery quality improvement goals in collaboration with senior management and stakeholders.Serve as a resource to multidisciplinary team assisting data analysis efforts in order to identify opportunities to improve patient care for selected surgical patient populations.Work actively with clinical staff to facilitate the highest possible performance on selected clinical quality measuresParticipate in the development and implementation of strategies to enhance continuous improvement in process and outcomes of assigned population(s)Educate clinical staff, students, residents, and faculty regarding surgery clinical quality measures performance on these measures.Educate clinical staff, students, residents, and faculty regarding opportunities to improve selected aspects of clinical care and the specific actions needed in order to achieve institutional goals for improvement on selected clinical quality measures.Actively participate on multidisciplinary quality improvement teams to meet organizational goals for selected clinical quality improvement initiatives.Develop and maintain positive, collaborative, supportive working relationships with the surgeons, nurses, administration, department management and staffPlan, organize, and prioritize work in order to meet organizational goals and objectives.Actively participate in readiness preparation and regulatory surveys as guided by the Director of Quality and Patient Safety.Provide education and support to colleagues and staff regarding quality improvementActively network internally and externally to develop skills, knowledge base, and opportunities to promote the quality initiatives. Participate in pertinent professional education to maintain current knowledge of best improvement practices for select patient populations.Utilizes hospital's cultural beliefs as the basis for decision making and to support the hospital's mission and goals.Participate on other improvement projects as assigned by the Director Quality and Patient Safety EDUCATION: Required: Baccalaureate in nursing; Masters' degree strongly preferred CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED: Licensed as a registered nurse in the Commonwealth of Massachusetts preferred. Certified Professional in Healthcare Quality preferred EXPERIENCE: At least 5 years of active clinical practice experience 2 or more years experience in clinical quality improvement strongly preferred KNOWLEDGE AND SKILLS: Strong computer skills including Microsoft Office platform-Word, Access, Excel, E-mail. Web/Internet. Ability to learn and effectively use computer software, such as electronic health records and data entry tools. Demonstrated skill and effectiveness in clinical quality improvement strongly preferred. Strong interpersonal skills; ability to establish supportive, collegial relationships; Excellent English communication skills (oral and written). For more information please send your resume to or apply here directly!

Please See Below for a Great Opportunity to get your foot in the door with one of the top Scientific organizations in the Tewksbury, MA area! This Opportunity allows for a lot of growth and ability to learn about Quality Assurance and Document Control lab practices!If interested please reach our directly to Richard Saad at rsaad@actalentservices.com or 781-917-1013!Description:The GMP Quality Assurance Associate II is responsible for upholding compliance and the maintenance of the Company's cGMP (Current Good Manufacturing Practices)/ISO Quality System.Responsibilities:Raw material review and releasePerform room/line clearancesReview of batch recordsRevision and creation of documents, including SOP's and formsLabel review and final inspectionCreate batch records, logbooks and controlled formsPerform GMP form reconciliationAssist with initiation, tracking and final distribution of approved documentsPerform any related work as required, based upon experience and training:Pest control reviewWeekly water reviewReview of manufacturing facility temperature and humidity dataSkills:Quality assurance, Audit, Gmp, raw material, batch record, iso, SOP, Quality ControlAdditional Skills & Qualifications:Associates Degree in Business Administration or related field0-3 years of experience in documentation management. Experience in manufacturing or chemical manufacturing environment preferredProficient in Microsoft Office and AdobeExcellent communication, interpersonal and organizational skills with the ability to manage multiple priorities and a strong attention to detailExperience Level:Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Sustainable Talent is teaming up with a global leader in clinical diagnostics, environmental, food, pharmaceuticals and cosmetics testing services, to grow their team. My client offers competitive compensation, full health benefits, and matched 401k.This position is based in Waltham, MA and is a Direct Hire Laboratory Technologist 2 position, with 2nd and 3rd shift availability.The pay is $26-30/hr. based on experience and location, with an additional night and weekend differential applied. Lab Technologist Job DescriptionFollowing prescribed procedures, performing any of the tests within any of the laboratory specialties, calculating the results of the tests performed as necessary.Operating, calibrating, conducting performance checks, and maintaining any laboratory analyzers or equipment.Recognizing and correcting basic analyzer malfunctions; notifying management personnel when appropriate.Preparing reagents or media from a prescribed procedure.Evaluating media, reagents, and calibrators according to established criteria. Conducting established quality control procedures on analytical tests, equipment, reagents, media, and products; evaluating results of quality control and implements corrective action when indicated.Conducting established quality control procedures on analytical tests, equipment, reagents, media, and products; evaluating results of quality control and implements corrective action when indicated.Determining performance specification for new methodsPerforms instrument maintenance, QC reagents and kits.Performs routine testing including assay validations.Contribute to process improvements.Monitoring quality assurance & continuous improvement programsMonitoring safety programs in compliance with laboratory regulationsUtilizes laboratory information systems or other methods to report patient results accurately and effectively.Reporting test results conforming to established procedures.Writing laboratory procedures conforming to standardized format including revising Standard Operating Procedures.Developing performance specification for new methods.Ability to instruct subordinate technologist in all aspects of medical laboratory testing.Training of new employees.Comfortable in interacting with inspectors (regulatory bodies; clients).Supports my client’s business philosophy, leadership values, and ethics.To meet my client’s quality policy and objectives, all employees are expected to meet basic expectations of my client’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.Lab Technologist Minimum RequirementsBachelor’s degree in chemical, physical, biological, or clinical laboratory science, or medical technology from an accredited institution.If required by the State in which the laboratory is located, the appropriate State License to perform clinical laboratory testing.2-4 years of related experience. Sustainable Talent is a M/F+, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. PI208248461

Central Admixture Pharmacy Services, Inc.PT PharmacistUS-MA-WoburnJob ID: 2023-22441Type: Regular Part-Time# of Openings: 1Category: PharmacyBoston (CAPS)OverviewCAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.CAPS is part of the B. Braun Group of Companies in the U.S. ResponsibilitiesPosition Summary: Responsible for the preparation compounded sterile products using and related activities under the direction of the Director of Pharmacy. Assists in the supervision of IV technicians, interns and other support personnel.Responsibilities: Essential DutiesPrepares compounded sterile products using aseptic technique and CAPS Standard Operating Procedures.Assures pharmacy compliance with rules and regulations of the State Board of Pharmacy and other regulating agencies.Reviews orders and prescriptions for admixing and dispensing. Resolves order discrepancies and problems with customer pharmacy personnel.Provides after hour On Call coverage.Expertise: Knowledge & Skills: Effective verbal and written communication skills.Ability to operate CAPS automation equipment.Ability to work well with other CAPS employees and the management team.Knowledge of cleanroom functions, aseptic technique, USP 797 and cGMP’s.Ability to interface with customers and apply good phone etiquette skills when speaking to customers.Ability to perform laboratory skills and Quality Control Coordinator functions as assigned.Knowledge of company polices and procedures and the ability to monitor for compliance.Computer literate in windows environment and computer systems.Ability to operate various types of office equipment.Target Based Range$56 - $70QualificationsExpertise: Qualifications - Experience/Training/Education/Etc: Required:BS/Pharm.D. Degree from accredited school of pharmacy.Licensure from the state board of pharmacy.As determined by supervisor.Participates in and delivers training as required. Desired:Two to three years of professional experience.Minimum of one year experience in preparation of compounded sterile products in a hospital or homecare pharmacy setting.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds..Additional Information Responsibilities: Other DutiesAssists in the training of IV technicians, interns and new staff pharmacists at the direction of the DOP.Participates in CAPS Continuous Quality Improvement Program and performs Quality Control Coordinator functions as assigned.Assists in pharmacy operation, including troubleshooting equipment problems, ordering supplies and maintaining inventory.Maintains a positive customer relationship.Perform other duties and responsibilities as assigned. Responsibilities: Supervisory Supervises IV technicians and interns, reviewing their work for accuracy while assuring compliance with CAPS Standard Operating Procedures.Provides employee performance feedback to Director of the Pharmacy.The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.Physical Demands:Ability to stand and/or sit for long periods of time.Ability to reach, grasp, stoop, pull and perform repetitive motion procedures.Ability to lift up to 20 lbs.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work Environment:Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating warm temperatures and loud noise.The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. What We OfferB. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.NoticesEqual Opportunity Employer Veterans/DisabledAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.PI208194089

The Opportunity: Clinical Supervisor Job Type: Full-time Pay: $78,000- $82,000k/ year    Who We Are || VOAMASS gives members of the community who need help the most the services, support, and self-esteem they need to create a fresh start. At VOAMASS, our dedicated teams are committed to serving the whole person.   What We Do || Through our powerful integrated behavioral health care model, we bring together vast resources from a diverse team of caring staff to help each client meet their personal goals. The care we provide paves the way for greater opportunity and second chances by focusing on the critical pillars towards a healthy life: behavioral health, financial stability, and safe housing.   Shiloh House ||The Hello House at Burt St provides comprehensive treatment to women coping with substance use and mental health disorders. More than an inpatient program, the goal at Shiloh House is to reintegrate its residents into the community and their families.   What you’ll do as Clinical Supervisor:   As Clinical Supervisor at the Shiloh House, you’ll have a dynamic and critical role ensuring the highest quality of care and practice by clinical staff at VOAMASS’ to our residential clients at our co-occurring recovery home in Shiloh. As Clinical Supervisor, you’ll report to the Program Director, serving as a thought partner and clinical leader. The Clinical Supervisor develops, implements, and trains on clinical policies and procedures and leads lead an incredible team of masters-level clinicians.     Clinical Supervisor Key Responsibilites: Oversee all Clinicial operations and supervise a team of masters-level clinicians Provide individual and group supervision of masters-level clinicians Coordinate and present clinical trainings and research to staff Ensure effective implementation of Evidence-Based Practices in group and individual counseling as well as Trauma Informed Practices. Conduct utilization review of clinical charts and coordinate with the multidisciplinary team to discuss complex cases Oversee admissions and discharge decisions. Responsible for reviewing all referrals to ensure clients meets program criteria Work collaboratively with staff to integrate case management and client centered interventions. Develop and oversee Clinical Staff schedule and assure appropriate coverage on unit. Monitor and review client cases, supervise treatment planning, and assure proper documentation in client charts to assure compliance with DPH and CARF and standards of care. Provide clinical consultation to other program staff as needed. Works in collaboration with the Residential Program Director a to ensure that all clinical documentation needed is completed and submitted in a timely manner. Other duties as needed.   The Clinicial Supervisor role is about making a difference in the lives of the people we serve. As Clinical Supervisor, you’ll bring the following qualifications: An advanced degree in Mental Health, Cunseling, Social Work, or a related field. Three years’ post licensure preferred. Licensed candidates (LMHC, LICSW, and LADCI) must hold an active license in MA. Licensed candidate who is able to provide supervision to Licensure Track and master’s-level clinicians, bachelor’s-level paraprofessionals, and recovery specialists in the program is preferred. Must have experience, competency, and/or training in both addiction and mental health. Prefer a minimum of five years in clinical settings as a clinician and two years of experience providing peer supervision to other clinicians. Knowledge of milieu therapy in residential settings; substance use modalities, harm reduction approaches, trauma informed care, whole person health approaches, dual diagnosis, and commitment to meeting the needs of the most vulnerable.   Since 1934, VOAMASS has provided critical services to the residents of the Commonwealth. From pioneering early residential treatment programs in the 1960’s to leading today in the field of mental health programming, VOAMASS can be counted on to tackle our greatest challenges. VOAMASS is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. For full-time employees, which includes our Clinicial Supervisor, our comprehensive and generous benefits package includes: Competitive Health, Vision and Dental insurance Flexible Spending and Health Reimbursement Account Employer paid Life and Long-Term Disability 403(b) matching retirement plans Tuition Remission Programs Loan Forgiveness (PSLF Program) Fitness/Wellness reimbursement Employee Discount Program Pet Insurance Blue Care Line (24/7 Nurse hotline) Generous Vacation, Sick, and Personal Time Benefits 13 Paid Holidays Employee Referral Bonus with no annual cap   Salary Description 78,000- 82,000/ yearVaccination Policy: In accordance with VOAMASS’ duty to provide and maintain a safe workplace, we have adopted a mandatory vaccination policy to safeguard the health of our employees and their families, our clients, partners, visitors, and the community at large from COVID-19. This policy complies with all applicable laws and is based on guidance from the Centers for Disease Control and Prevention and the Massachusetts Department of Public Health. PI208359278