QC Manager Jobs in Massachusetts

Job Title: Manager Quality Control Company: Genzyme Location: Westborough, MA Description: Genzyme Genetics is an award-winning national provider of highly sophisticated diagnostic testing, including prenatal, postnatal and neonatal as well as oncology testing. We are one of the largest diagnostic locations around the United States and a growing international portfolio. We also provide Genetic Counseling services. We are best known for our high quality, innovation, unique menu and commitment to a clear and positive impact on patient care. Additionally, we are a leader in personalized medicine and forging relevant connections between diagnostics and therapeutics.As a division of Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, we are committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme Corporation has been selected by FORTUNE magazine as one of the 100 Best Companies to Work For in 2006 in the United States, and ranked #6 Employer among the worlds Top 20 Biotechnology and Pharmaceutical Companies.SummaryWe are currently seeking a Quality Control Manager for our high throughput clinical molecular genetics testing laboratory in Westborough, MA. This hands-on manager will be responsible for supervising the daily activities of a QC team dedicated to supporting the sample extractions and assay laboratories, as well as providing some support for other sites within the Genzyme Genetics network. This is a highly technical role providing oversight of the teams responsibilities to provide high quality reagents and materials to numerous internal customers.This individual will also serve as one of the organizations technical experts on a variety of assays, providing support in the areas of experimental design and analysis, troubleshooting, and continuous process improvement.Job ResponsibilitiesManage the day-to-day activities of the laboratorys Quality Control operations, including the methods and processes surrounding the provision of high-quality reagents to theclinical molecular genetics laboratory. Provide leadership, support and direction and ensure compliance with all QC SOPs. Assign and prioritize team and individual QC responsibilities. This includes the supervision of a small team and all related personnel management responsibilities such as hiring, goal setting, team building, and performance evaluations.Review molecular and other QC data, according to laboratory SOPs and CLIA and CAP standards. Coordinate approvals, troubleshooting, and problem resolution in collaboration with clinical assay supervisors.Oversee the qualification of several hundreds of reagents and supplies. Develop qualification procedures and acceptance criteria for all qualified reagents. Analyze QC data in conformance with in-house, generally accepted clinical DNA diagnostic laboratory and, increasingly, in accordance with cGMP standards for quality. Establish QC metrics for the continuous monitoring of reagent performance in production.Apply deep technical knowledge in clinical chemistry, molecular biology, or biochemistry to provide high-level technical expertise on the troubleshooting of current assays and the scale-up and transfer of new assays and technologies into the production laboratory. Mentor team members in the application of good experimental design, using statistical dataanalysis and DOE what is this? where applicable.Develop processes for the controlled release and tracking of quality-controlled reagents to on-site and remote testing laboratories. Manage all production supply ordering and inventory tracking in collaboration with the Materials Management group.Develop new SOPs and perform SOP revisions while adhering to formal document control procedures and regulatory requirements.Serve as primary QC contact; maintain inter- and intra-group interactions through effective communication; coordinate critical QC interactions with other areas of the molecular genetics lab; collaborate with QA, Development and Assay groups in technical transfer of new tests according to launch timelines; participate in weekly Supervisors meetings; participate in Core teams for new product development and launch by providing review and recommendations on technical aspects of project.Initiate and perform change controls for instrumentation, processes, and materials related to the quality control processes.

Job Title: Clinical Research Operations Quality Manager Company: Genzyme Location: Cambridge, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.PURPOSE OF THE POSITION: To implement and manage internal quality control and oversight procedures in Clinical Operations to secure and maintain compliance with ICH GCP and other applicable international regulations, as well compliance with internal SOPs, systems, processes and standards. The position will instill concepts of quality management, continuous improvement, and inspection readiness so that Clinical Research programs can consistently withstand inspections by internal QA or external regulatory authorities globally.CORE RESPONSIBILITIES:Analyze and track all audit reports globally (internal QA or Regulatory Authority audits) to insure that responses and corrective actions applicable to Clinical Operations are completed and audits are closed in a timely manner.Generate, coordinate, and track Corrective and Preventative Action Plans (CAPA) within Clinical Operations.Determine the need for new processes or revisions to processes (e.g. SOPs, Work Instructions).Determine the need for training programs or revisions to training curricula.Act as the primary contact and resource for Clinical Operations during regulatory inspections by competent authorities. Support project teams and coordinate resources in planning and responding during inspections.Track and ensure that all staff in Clinical Operations is current with training requirements.Assist in the review and development or revision of processes and best practices (SOPs).Assist in the development of training programs in Clinical Operations (SOPs and GCP).In collaboration with other process owners in Clinical Operations (e.g. Monitoring, TMF), evaluate metrics for compliance with predetermined performance criteria, particularly in regard to study monitoring and reporting functions (e.g. Monitoring Visits, report generation, Monitoring Manual preparation and compliance).Establish and manage inspection readiness requirements so that all documents and systems are up to date and readily accessible (e.g. Trial Master File maintenance, Clinical Trial Management System maintenance and other requirements)Develop a Compliance Plan for Genzyme staff, contractors, vendors and CROs and track conformity to the compliance plan - CVs, Job Descriptions, organizational charts, training records.Develop Inspection Readiness guidance documents and training to assist project teams in establishing inspection readiness both internally, and with vendors or contract research organizations.Train and lead staff in quality and continuous improvement initiatives.Develop compliance and performance dashboards along with periodic summary reportsDevelop and maintain business continuity plans and contact information required during disruptions of normal business functions.

Job Title: Quality Control Manager Company: PCI Synthesis Location: Newburyport, MA Description: Requirements: Minimum of a Bachelor’s degree in chemistry or related field, plus experience supervising employees in a current Good Manufacturing Practices (cGMP) quality control or analytical laboratory with thorough knowledge of GMP principles. Skills: Excellent written, verbal and interpersonal skills; strong ability to prioritize in a dynamic environment; proficient with Microsoft Office; self motivated and able to work independently when necessary; set goals, organize and follow project plans; detail oriented and willing to follow through on all aspects of a task required for successful, timely completion.Responsibilities:Proactively perform Quality Control (QC) function in full compliance with cGMP. Schedule work flow and supervise QC Analysts. Oversee and lend support to laboratory personnel in testing raw materials, in-process samples, finished product, and stability samples. Setup and maintain Statistical Process Control (SPC) system in the QC laboratory. Maintain electronic database and perform trend analysis on batch and raw material data. Participate as an active member on the various cross functional improvement teams. Review and approve analytical method: development reports, validation protocols and validation reports. Conduct lab Out Of Specification (OOS) investigations. Transfer of validated methods from Method Development to Quality Control. Improve existing standards/specifications by recommending changes to Director. Conduct hands-on-training for all QC chemists and technicians. Maintain the laboratory in compliance with the company’s cGMP and Environmental Health and Safety (EH&S) procedures.Email resumes including salary history and requirements.No recruiters or phone calls please.

Job Title: Quality Manager Company: The Judge Group Location: Quincy, MA Description: Primary Duties and Responsibilities:- Establish, implement and maintain a rigorous Quality Management System.- Develop and implement Supplier Metrics such that company sourcing is directed to high performing Suppliers.- Qualification of global suppliers (specifically Asia)- Drive Suppliers for root cause analysis and process improvements that eliminate repeat quality occurrences.- Using a standardized, documented approach to ensure the Qualification of new suppliers.- Work cross-functionally with Engineering to develop new products that meet Quality standards- Development and execution of standard product testing criteria.- Fully integrate standardized processes, built-in quality, employee engagement, data driven quality system throughout the Manufacturing process.- Work cross-functionally with Customer Service to resolve field issues and reduce RMA's.- Hire and develop a forward thinking, high quality organization.- Organize and lead internal teams in Lean and SS activities.Qualified candidates must have:- BS in Engineering, Quality or related field- 7-10 years leading a Quality function in a manufacturing environment- Thorough working knowledge of Quality systems- Demonstrated ability to develop and implement Quality systems through the supply chain- Demonstrated ability to lead and develop a highly skilled Quality organization- Knowledge of the plumbing industry and its supply chain is a significant benefit.- Working knowledge of manufacturing processes such as casting, forging, machining, plating and injection molding.- ASQE or similar certification

Job Title: Assoc Director Quality Company: Genzyme Location: Allston, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.Quality Assurance Associate Director, Allston, Bulk Protein ManufacturingJob Responsibilities/Department description:This individual will report to the Director of Quality Assurance Operations for Allston and will be responsible for providing leadership and technical management of the Quality Assurance group supporting Bulk Protein Manufacturing Operations. The position will have five direct reports. The primary responsibilities of the group include real-time oversight of manufacturing operations (buffer and media prep, cell culture, purification, and formulation); product release; continuous improvement; and approval of master documents and executed records.Major responsibilities include:Develop, improve, and monitor quality systems to achieve best in class performanceEnsure departmental and site procedures are aligned with regulatory requirements and corporate quality standardsActively partners and collaborates with key stake holders during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones consistent with site priorities and objectives.Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, and encouraging constructive relationships with manufacturing and support groupsSupport an environment of staff development and learning; mentoring and developing personnel, including supervisory/management staff via timely feedback, robust developmental discussions, and documented goals/objectivesDevelop and execute hiring plans, ensuring that requisitions are filled in a timely mannerOversee record review and lot release processes for bulk intermediatesManage immediate response to deviations, in partnership with other operations groups; identify, contain and mitigate risk in a 7 day/3 shift working environment; ensure thorough investigation of root causes, and the implementation of effective CAPAsApprove validation plans and protocolsDevelop and manage departmental budget in cooperation with direct staffThe Quality Assurance Associate Director works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors; exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Job Title: Quality Control Manager Company: North Coast Seafoods Location: New Bedford, MA Description: North Coast Seafoods is a leading provider of exceptional quality fresh & frozen product.  We are currently seeking an energetic, highly motivated candidate who possesses the desire to have a career in quality assurance and enjoys seafood to work in our New Bedford facility. The ideal candidate must be able to multi-task, have excellent communication skills (bilingual a plus), and possess attention to detail skills.  Must be familiar with MS Word and be able to generate daily quality reports for viewing by senior management.   The candidate must have flexibility in his/her day and have the desire to learn and expand ones knowledge of the seafood industry.  Knowledge of HACCP and specific knowledge of the seafood industry is a plus.  The ideal candidate must also be self-motivated and possess an excellent work ethic.   Compensation will be commensurate with experience.  In addition, we offer health, dental, life, long-term disability, paid vacation and a 401(k) with company match.  We are an Equal Opportunity Employer and provide a drug-free work environment. Please send resumes and salary requirements to North Coast Seafoods.

Job Title: Manager of Quality and Compliance Company: Charles River Medical Associates Location: Framingham, MA Description: Description The Manager of Quality and Compliance will be responsible for implementing and managing quality improvement programs as well as managing all medical practice Compliance functions for staff and providers. This role will have the primary responsibility of monitoring, reporting and developing/implementing tools to improve Charles River Medical Associate's (CRMA) quality and efficiency performance in our health insurance payer contracts; working with colleagues throughout the Partners Community Healthcare Inc. (PCHI) and Partners network.. Additionally, this role will be responsible for creating deeper collaboration among PCHI-Partners entity staff for quality improvement programs. A car and driver’s license are necessary due to occasional local travel between medical offices and various Partners sites. Office location for this position can be flexible. Responsibilities The Manager will lead the programmatic strategies for CRMA, in planning, facilitating, implementing, and operation of programs that enhance the dual missions of quality of care and efficiency, along with delivering the Compliance strategy as directed by Corporate Management. Quality responsibilities will include development and maintenance of quality assurance, physician incentive, patient satisfaction and clinical quality and efficiency programs. Compliance responsibilities will include serving as CRMA's Compliance and Privacy Officer; implementation of compliance goals; compliance related audits and assessments; compliance training for staff and providers and oversight of ancillary services certifications programs (ICAEL, AAAHC, ACR, ADA ) Qualifications A minimum of 3-5 years of related healthcare experience with some of those years responsible for Quality and Compliance. A bachelor’s degree is required. Experience within a complex healthcare system, integrated delivery system, or large medical group, providing the understanding of both large system coordination strategies and the relationship between corporate support and operating programs. Project management experience a big plus.Experience with relational databases is required. In particular, Microsoft Access. Candidate must be proficient with Microsoft Excel. Candidate must be familiar with billing compliance rules as well as clinical terminology. About CRMA CRMA is a 50-physician multispecialty group practice with many locations in the Framingham/Natick/Marlboro region. It is affiliated with Partners Healthcare.

Job Title: QC Manager-Microbiology Company: Hyaluron Inc Location: Burlington, MA Description: JOB SUMMARY: The QC Manager is responsible for the oversight, scheduling, and performance of microbiological testing of raw materials, in-process samples, finished formulations; and QC inspections of manufacturing processes. JOB RESPONSIBILITIES:Oversight, scheduling and performance of:1. Microbiological testing for incoming, in-process and final products.2. Environmental monitoring.3. Instrument maintenance, calibration and validation.4. Media fill inspections.5. QC inspections and process checks/verifications.6. Aseptic proficiency testing.7. Employee gowning qualification.8. Line clear and line start verifications.9. Quarantine and release activities for in-process and final product materials.10. Inspection of assembly and kitting.11. Inspection of product shipments.12. Routine sampling and testing of the USP Purified Water System and clean steam. Responsible for:1. Review of QC data, log books and classified area log books.2. Environmental monitoring trending and monthly reports to management.3. Maintain historical files on organisms found in classified areas; microbial identification and trending; monthly trending analysis reports to management.4. Responsible for investigation deviations and reporting on monthly metrics. MINIMUM REQUIREMENTS FOR EDUCATION, TRAINING AND EXPERIENCE:1. Must be skilled in the use of computers and proficient in the use of word processors and spreadsheets.2. Strong organizational skills, ability to prioritize and multi-task.3. Minimum of three years supervisory/management experience in QC Microbiological laboratory, plus minimum of five years industry experience.4. Bachelors degree in scientific discipline.5. Knowledgeable in FDA, GMP's (21 CFR, 211, 820, 58 and/or 600)6. Knowledge in ISO 9001 and 13485 a plus.MANAGERIAL AND SUPERVISORY RESPONSIBILITIES:Responsible for the management of the QC Microbiological Laboratory and QC Inspections of manufacturing processes.

Job Title: Director Quality Mgmt Biologics Company: Millipore Location: Billerica, MA Description: Millipore is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world’s challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Millipore Corporation is an S&P 500 company with 6,000 employees in 47 countries worldwide.Quality Assurance Director, Biologics will be responsible for overseeing the quality teams located for the Bioscience Division.Locations included: Cork, Ireland; Molsheim, France; Dundee & Cambridge, UK; Sao Paolo, Brazil, St. Charles, Missouri, Temecula & Ramona, CA; Danvers, MA and Melbourne, Australia.This individual will be responsible for developing and implementing effective and consistent corporate quality systems. S (He) will support and provide guidance to the R&D efforts and products manufactured for the Bioscience Division of Millipore.The Quality Assurnce Director will interact across functional areas including, but not limited to, Research & Development and Manufacturing. S (He) will have exposure to Millipore’s customers with regards to quality standards.KEY POSITION RESPONSIBILITIESDrive external benchmarking of industry quality§ standards and lead implementation of quality best practices in all Millipore manufacturing sites.Lead implementation of quality system§ improvements.Develop and manage corporate wide implementation plans which§ will include communication, training, consulting, and auditing for compliance.Set goals for manufacturing quality improvement. Ensure effective§ metrics with targets are utilized to track company-wide manufacturing quality improvement results to goals. Based on results, mitigate issues including, reallocation of global quality resources (people, financial, etc.) to drive attainment of goals.Ensure that site practices are consistent within the§ division and consistent to corporate wide standards, as appropriate.Identify quality improvement opportunities within operations§ and partner with Quality Systems and Engineering groups to develop and implement solutions.Develop staff both at corporate and site levels, including the§ generation of development programs, both professional and technical, as well as succession plans.Keep senior management apprised regarding product issues and quality improvement plans. The Director of Quality will be charged with developing a cohesive team across the Bioscience Division. S (He) will have built relationships with their corporate peers including other Quality executives, Supply Chain, Product Management, SBU heads and Research & Development. The successful candidate will implement quality systems & tools to enable continuous improvement plans.The ideal candidate will have 10-20 years in R&D, Validation, Engineering, Regulatory, Production or Quality functions in a regulated environment. 10 of those years will have been in quality management roles.S (He) will have a Bachelors of Science degree in Biology, Pharmacy, Life Sciences or Engineering.The ideal candidate will have multi-site, quality management experience in one of the following industries; Diagnostics, Medical Device, Biotechnology, or Pharmaceutical. S (He) will have working knowledge of all areas of manufacturing and be effective in partnering with them in order to get products safely to market.The chosen candidate will have proven experience in developing and implementing best practices across multiple sites and ensure consistencies globally.In addition to being a Quality executive, this individual will have had prior experience with Regulatory.The ideal candidate will be a change agent. S (He) will bring a high level of leadership to the quality department and be effective in training and mentoring teams.This individual will have a positive, can do attitude and will be able to rally teams to drive towards a common goal. S (He) must have strong influencing skills with the ability to communicate across all levels and functions within the organization. The ability to gain consensus with groups is a must.Experience in recommending and implementing new quality systems and tools in order to grow with the business is a must.This individual must be an executive with the ability present ideas to the senior management team and effectively gain buy in for new initiatives. S (He) will have a strong executive presence. REQUIREMENTS - QUALIFICATIONS: Director Quality Mgmt Biologics See Information AboveMillipore

Job Title: Director Quality Company: Genzyme Location: Framingham, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.Director Validation -Framingham Biologics SiteJob Responsibilities:Develops/defines the overall validation strategy and vision for Framingham Biologics Facility in alignment with evolving corporate and global validation requirements, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment. This position will report directly to the Site Quality Head and be a member of the Quality Leadership Team and site Quality Council.Routinely assesses and determines optimal organizational structure and resource requirements to assure compliant performance and timely completion of priorities in a 7day/3 shift working environment.Insures and procures adequate staffing levels to flawlessly maintain validation requalification program, projects and continuous improvement initiatives. Manages all aspects of Operations Automation validation including utility, equipment, infrastructure, application, systems and there interface to defined enterprise solutions.Provides senior management and staff key input, direction and leadership in support of complex validation challenges related to site initiatives and objectives.Directs the development, planning, implementation and maintenance of validation methods, processes and operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Oversees validation schedules, ensuring compliance with appropriate regulatory agency validation requirements, internal company standards and industry current practices.Actively participates and influences the development and formalization of corporate validation standards, policies and guidelinesActively partners and collaborates with key stake holders during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones consistent with site priorities and objectives.Mentors and develops personnel, including supervisory/management staff via robust developmental discussions, external feedback and documented goals/objectives.Routinely assesses key talent and establishes a succession plan for all managerial personnelDefines framework for department objectives, operation schedule, processes and budgets.Provides key input and documentation during external and internal regulatory compliance inspections. Assures validation requirements are always in state of inspection readiness.Develops key performance indicators that will drive validation performance expectations and improvement.Work is performed without appreciable direction. Determines organizational objectives. Completed work is reviewed, from a relatively long-term perspective, for desired results.Generally accomplishes results through lower management levels.