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QC Supervisor Jobs in Massachusetts

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Job Title: Supervisor Quality Control, Weekend, 2nd Shift
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.QC Microbiology Supervisor, Weekend, Second ShiftJob Responsibilities/Department description:-Supervise operations of the QC Microbiology Laboratory for Weekend Second shift operations including direct responsibility for 2 analysts.-Oversee ELISA, endotoxin, bioburden, Environmental Monitoring, critical utilities collection and testing.-Ensure GMP compliance of all activities performed.-Represent QC Micro in internal and external audits as required.-Oversee and plan QC Micro validation and revalidation of lab equipment and campaigns supported by QC Microbiology (cGMP).-Ensure appropriate facility support and provide technical expertise-Coordinate and support validation, engineering and production assignments according to schedule without compromising quality.-Specify, procure, and coordinate validation, calibration and maintenance of laboratory equipment and instrumentation.-Review standard operating procedures; coordinate method development, alignment and validation as required.-Maintain positive relationship and network effectively across sites and organizations.-Documentation of laboratory deviations, incidents and investigations.




Job Title: Quality Control Supervisor
Company: Genzyme Corporation
Location: Framingham, MA

Description:
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. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's 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. Genzyme's 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 Control SupervisorThe candidate will work in the Quality Control Microbiology department and be responsible for the day to day supervision of a small group supporting aseptic processing and fill finish activities. The supervisor will be responsible for overseeing microbiological assays, including environmental monitoring, and will be expected to cover QC activities in the clean room during aseptic processing as needed. The supervisor will conduct assay and OOS investigations, review and amend standard operating procedures and documents, and perform annual performance reviews.Major Responsibilities:1. Supervise QC operations and provide Quality oversight during aseptic filling operations, including environmental monitoring, personnel monitoring, and Quality oversight of clean room practices, cleaning, and documentation.2. Assure compliance to EC Guide to Good Manufacturing Practice: Annex 1, and Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, FDA and other global guidances.3. Collaborate with Manufacturing clean room operators and QA to identify and resolve quality issues in the clean room through frequent communication.4. Involvement in media fills.5. Perform gowning qualification of clean room personnel, including data reporting and trending.6. Implement harmonized clean room practices such as gowning and aseptic manipulations.7. Involved in investigations and excursions.8. Author procedures and reports.9. Assist in environmental monitoring review, trending and reporting.10. Maintain inspection ready procedures and reports for audits and regulatory inspections Qualifications Basic Qualifications:Bachelor's degree in Microbiology or Biological Sciences. Must have 5 - 8 years Quality Control experience in pharmaceuticals or biotech industry, with aseptic processing experience. The candidate should possess strong computer skills for the utilization of LIMS. Preferred: This candidate must have good communication skills and possess a high degree of leadership and professionalism. The candidate should have knowledge of global GMP regulations for pharmaceuticals and medical devices. If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id Register to View -6972




Job Title: Quality Control Supervisor
Company: ASSOCIATES OF CAPE COD
Location: East Falmouth, MA

Description:
ASSOCIATES OF CAPE COD, INC., is a leading manufacturer/worldwide distributor of endotoxin reagents for the medical device/pharmaceutical industries.  We offer a competitive salary, 401(k) plan and excellent benefits.Quality Control Supervisor – Candidate will  be responsible for the review, interpretation and trending of data from chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples in accordance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Candidate will schedule all group activities, personnel management, training and support, coordinate testing priorities with other departments.   Candidate will also conduct performance management and development, including performance reviews and objectives, interviewing and hiring. Bachelor’s degree in related science field with 6+ yrs of experience in the medical device, biotech or pharmaceutical industry, advanced degree preferred.   At least 4 years supervisory experience preferred.TO APPLY PLEASE VISIT OUR WEBSITE:  WWW.ACCIUSA.COM




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