QC Analyst I/II Materials
Organogenesis
Full-time
Remote friendly (Canton, MA)
United States
Operations
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Role Summary
The QC Analyst I/II (Materials) performs quality activities in support of material inspection, material testing coordination, data collation, data review, and material disposition in support of Clinical and Commercial Operations and Quality Control testing. The role interacts with internal departments and external entities, ensuring compliance with applicable regulatory requirements by inspecting, coordinating testing, trending, and reporting results. Periodic weekend, holiday, and evening on-call coverage may be required.
Responsibilities
- Perform material inspections.
- Perform tissue inspections.
- Submit test requests to the QC functional areas to coordinate testing.
- Coordinate shipping of materials to external test labs.
- Perform sampling of various chemicals.
- Collate results and document results to submit to Quality Assurance for final dispositioning.
- Generate trend reports as they relate to Quality Control testing.
- Revise SOPs.
- Maintain equipment and inspection tools.
- Support material qualifications.
- Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
Qualifications
- Bachelor’s Degree in Science or equivalent
- 1-4 years of related experience in a cGMP regulated environment
- Materials and/or final product inspection experience required
- Pharmacopeia experience required
Physical Demands
- Able to lift 50 lbs. and 50% of time standing in workday
Education
- None specified beyond the bachelor’s degree requirement above