Overview
QA Specialist III Jobs in Winston-Salem, NC at Meet Life Sciences
Title: QA Specialist III
Company: Meet Life Sciences
Location: Winston-Salem, NC
Job Summary
The QA Specialist III provides independent, real-time quality oversight within classified manufacturing environments, including cleanrooms, supporting cell therapy production. This role ensures compliance with cGMP standards through on-floor presence, documentation review, and proactive issue identification. The position requires full-time onsite work, including shift coverage, gowning, and close collaboration with cross-functional teams to maintain compliant and efficient manufacturing operations.
Responsibilities
- Provide QA oversight and review of moderately complex manufacturing operations in classified environments.
- Maintain continuous on-floor presence to support production, ensure compliance, and resolve issues in real time.
- Perform detailed in-process batch record reviews and verify documentation accuracy and completeness.
- Review manufacturing records, environmental monitoring data, and related documentation.
- Execute and verify line clearance activities.
- Identify, document, and resolve standard quality issues; escalate complex or high-risk issues as needed.
- Support deviation investigations, CAPA activities, and 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 procedures.
Qualifications
- Bachelor’s degree in an applied science field or equivalent experience.
- Minimum of 5 years of QA experience in a GMP-regulated manufacturing or quality environment.
- Aseptic manufacturing experience preferred.
- Strong knowledge of cGMP regulations and quality systems.
- Ability to evaluate and resolve moderately complex quality issues with sound judgment.
- Ability to manage multiple priorities with minimal supervision.
