QA Specialist III

The QA Specialist III provides independent, real-time quality oversight within classified manufacturing environments, including clean rooms, 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.

• 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; escalation 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.

• 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.