QA Specialist, Drug Product
On-siteHolly Springs, North Carolina, United States
Job Summary
Support the development of documents, processes, and procedures for the Drug Product program while assessing the impact of system and process modifications. Provide oversight and approval of system and process lifecycle documentation, including risk assessments, specifications, and validation plans. Generate, review, and approve QA procedures for operational readiness objectives and cGMP manufacturing operations. Ensure fulfillment of project and operational quality objectives within desired timelines. Provide Manufacturing shop floor support including Acceptable Quality Limit verification, critical process step checks, line clearance, and alarm response. Participate in optimization initiatives and support regulatory agency and third-party inspections. Requires a Bachelor's or Master's degree in Life Sciences or Engineering with experience in GMP regulated environments. Located in Holly Springs, North Carolina.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering or equivalent
- 2+ years of applicable industry experience
- Master's degree in Life Sciences or Engineering
- 1+ years of experience working in a GMP regulated environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility
- Ability to ascend or descend ladders, scaffolding, ramps, etc.
- Ability to stand for prolonged periods of time, up to 60 minutes
- Ability to sit for prolonged periods of time, up to 120 minutes
- Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
- Ability to conduct work that includes moving objects up to 10 pounds
- Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions
Desired Qualifications
- High level understanding/familiarity of validation of production equipment, hygienic utilities, quality systems, automation, methodologies, manufacturing and IT Systems
- Understanding of GAMP5, Data Integrity and application of 21 CFR Part 820 and Part 11
- Understanding of formulation, aseptic filling and/or visual inspection
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