What are the responsibilities and job description for the QC Analyst III-Cell Culture (Sunday-Thursday) position at Organogenesis?
About Us
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.
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What You Will Achieve:
This position is a Sunday – Thursday shift with initial training occurring Mon-Fri for approx. 6 months before transitioning to the Sunday – Thursday requirement. Occasional holiday hours may be required to maintain ongoing cell cultures.
The QC Analyst III performs advanced quality activities in support of product production and releases with minimal supervision. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
This position also requires repetitive hand movement e.g. micropippetting and keyboard use for moderate or long periods of time. Occasional Class 10K gowning is required to support QC activities.
How You Will Achieve It:
- Primary responsibility for the day-to-day activities in the Cell Culture laboratory in support of product release testing.
- Scientific/technical contributor on cross-functional projects related to all Cell Culture activities and assay development/optimization.
- Interact and coordinate with Manufacturing and QA Operations daily.
- Coordination of test sample receipt and scheduling.
- Execute assigned tasks with minimal supervision.
- Donated tissue receipt and transfer.
- Identify and report areas for process improvement.
- Generate and execute feasibility/validation protocols.
- Generate trend reports as they relate to quality testing.
- Work closely with team members to ensure timely release of materials.
- Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
- Revise/Create SOPs.