Description
Oversee all Quality Control (QC) SOPs, QC Methods, unplanned events, Change Controls, CAPAs, continuous method validation, and QMS events for drug substance quality control activities. Drive excellence in Quality Control. Join us as an Operational Quality Specialist in Quality Control. You will be at the heart of ensuring high-quality standards are met across manufacturing and testing operations.
Responsibilities:
- Provide oversight to all QC related quality system activities and take initiative to resolve and/or escalate concerns including Deviations, CAPAs, Change Controls, Validation, Analytical Method Transfers, Risk Assessment, and PQRs.
- Demonstrated familiarity and compliance with GMPs, EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
- Responsible for release of the rooms after the Return to Service testing for the lab areas and for status changes of lab areas in response to maintenance work or unplanned events.
Principle Decisions and Complexity:
- Decisions made for Quality directly impact the quality and suitability of the products produced at the Marietta site including the release of clinical trial materials and commercial products.
- Manage a high number of projects in parallel. Priorities can change very quickly due to new business opportunity or new sales projection.
Basic Qualifications:
- Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline.
- 2+ years of quality control experience and experience overseeing quality control testing.
- Prior experience with licensed biopharmaceutical or biological products preferred.
- Hands on experience using Analytical laboratory equipment/systems, such as HPLC, GC-MS, TOC, FTIR, ELISA is preferred.
Work Arrangement:
- This role is on-site at a United States manufacturing location. Regular presence in production and laboratory areas is required. Hybrid or remote work is not available.