Quality Assurance Specialist
Quality Assurance Specialist III - Manufacturing Quality Operations
Location: Winston‑Salem, North Carolina
Employment Type: 6 month Contract, Hybrid
Shift: As Assigned
Department: Quality Assurance / Manufacturing Quality Operations
Reports To: Associate Manager, Manufacturing Quality Operations
About the Role
We are seeking an experienced Quality Assurance Specialist III to provide independent, real‑time QA oversight within classified manufacturing environments, including cleanrooms. This is a hands‑on role supporting day‑to‑day GMP operations, ensuring documentation accuracy, regulatory compliance, and efficient manufacturing processes.
This position is 50% onsite due to the nature of the work, requiring full gowning, frequent cleanroom presence, and continuous collaboration with Manufacturing, Facilities, Quality Control, and other functional teams.
Key Responsibilities
- Provide QA support for moderately complex manufacturing activities within classified environments.
- Maintain a consistent on‑floor presence to support production, resolve issues, and uphold compliance.
- Perform complex in‑process batch record reviews and verify documentation accuracy.
- Review manufacturing records, environmental monitoring data, and related documentation.
- Conduct and verify line clearance activities for assigned manufacturing processes.
- Identify, document, and resolve standard quality issues; escalate non‑routine or higher‑risk concerns.
- Support deviation investigations, CAPAs, and related remediation efforts.
- Review and approve facility alarms, work orders, and return‑to‑service documentation.
- Participate in internal audits, inspections, and cross‑functional quality initiatives.
- Adhere to all gowning, safety, and cleanroom protocols.
Education & Experience
- Bachelor's degree in an applied science discipline, or equivalent relevant experience.
- Minimum 5 years of QA experience in a GMP‑regulated manufacturing or quality environment.
- Experience in aseptic or sterile manufacturing is highly preferred.
Skills & Competencies
- Strong working knowledge of cGMP regulations and quality systems.
- Ability to exercise sound judgment when addressing moderately complex quality issues.
- Excellent documentation, analytical, and problem‑solving abilities.
- Effective communicator with strong cross‑functional collaboration skills.
- Able to manage multiple priorities with limited supervision.
Working Conditions
- Full‑time onsite role within a GMP manufacturing environment.
- Not eligible for hybrid or remote work.
- Requires full gowning and extended periods working in cleanrooms and classified areas.
- Ability to stand for long periods and perform necessary physical tasks.
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