Quality Assurance Specialist 3, Floor Support

Job description

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. Essential Duties & 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 d...