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Quality Control Analyst II This is a Quality Control position within a clinical stage biotechnology company that focuses on gene therapy, severe genetic diseases and cancer immunology. As a Quality Control Analyst II reporting to the Associate Director, Quality Control, you'll help patients by: - Performing cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA) - Reviewing and evaluating raw data (peer review level) - Author SOP's / Forms and technical reports with guidance - Initiating laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance - Author, review, and execute equipment validations with guidance -Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training) - Executing phase-appropriate test method validation protocols as needed - Participate in providing the necessary information for regulatory filings and inspections. - Supporting CAPA/Continuous Improvement Initiatives

You're the person we're looking for if you have:

- BS with 4 - 7+ years in a biotechnology discipline or MS 2 - 4+ years - 4 - 7+ years of experience in a cGMP/GxP environment is preferred - Preferable hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA - Superb organizational, analytical, and communications skills and "do-what-it-takes" attitude - A passion for addressing the critical unmet medical needs of patients - Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment

This is an excellent opportunity to join a well established biotechnology company in Cambridge that is working to help patients with terminal illness.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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