Quality Assurance Specialist 3, Floor Support
About The Position
Position Summary The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations. This role is an onsite position in Winston Salem, NC requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real-time nature of quality activities, this role is not eligible for remote or hybrid work.
Requirements
- Bachelor’s degree in an applied science field or equivalent experience.
- 5 years of QA experience in a GMP‑regulated manufacturing or quality environment
- Solid professional knowledge of cGMP regulations and quality systems.
- Ability to apply judgement to moderately complex quality issues.
- Strong documentation, analytical and problem-solving skills.
- Effective cross-functional communication and collaboration.
- Ability to manage multiple priorities with limited supervision.
Nice To Haves
- Aseptic manufacturing experience preferred.
Responsibilities
- Provide QA review of moderate‑complexity manufacturing operations in classified environments.
- Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.
- Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy.
- Review manufacturing records, environmental monitoring data, and related documentation.
- Perform and verify line clearance activities for assigned processes.
- Identify, document, and resolve standard quality issues; escalate higher-risk or non-routine issues as required.
- Support and contribute to deviation investigations, CAPAS, and remediation activities.
- Review and approve facility alarms, work orders, and return‑to‑service documentation.
- Participate in internal audits, inspections, and cross‑functional quality initiatives.
- Follow all gowning, safety, and cleanroom behavior requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
