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Cell Culture Quality Assurance Specialist
1 month ago
We are a leading developer of advanced wound care products and regenerative medicine solutions. Our mission is to empower healing and improve the lives of our patients. We are committed to innovation, quality, and excellence in everything we do.
Job Summary
We are seeking a highly motivated and detail-oriented QC Analyst I, Cell Culture to join our team. The successful candidate will be responsible for performing quality activities in support of product production and release for our ASA product. This includes conducting testing, trending, and reporting results to ensure compliance with applicable regulatory requirements.
Key Responsibilities
• Perform daily lab housekeeping and maintenance, including temperature charting, restocking, cleaning, and sample receipt, logging, and disposition.
• Conduct routine and non-routine testing of ASA in support of Stability, Process Validation, and Method Validation.
• Report and review final product results, and participate in data analysis and review.
• Interact with Quality Assurance, R&D, and Manufacturing teams, and work closely with the QC Chemistry lab in support of cell-based potency assays.
• Participate in receipt, inspection, and transfer of tissue donations for both the ASA and Affinity Product lines.
• Collaborate on deviation reports, out-of-specification reports, CAPAs, Change Controls, and non-routine investigations.
• Revise and review SOPs.
Requirements
• Bachelor's degree in biology or related field, with 1-3 years of related experience.
• Lab experience required, with experience in Biologics/chemistry and GMP regulated environment preferred.
What We Offer
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from diverse candidates.
