QA Specialist III

Meet Life Sciences; Winston-Salem (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Meet Life Sciences is seeking a QA Specialist III to provide independent quality oversight in classified manufacturing environments for cell therapy production. The role requires full-time onsite work with gowning, shift coverage, and collaboration across cross-functional teams to maintain compliant operations.

The candidate should have a bachelor’s degree in an applied science and at least 5 years of QA experience in GMP settings, with aseptic manufacturing experience preferred.

Qualifications

• Minimum 5 years of QA experience in a GMP-regulated environment.
• Strong knowledge of cGMP regulations and quality systems.
• Ability to evaluate and resolve moderately complex quality issues with good judgment.
• Experience with aseptic manufacturing is a plus.

Responsibilities

• Provide QA oversight of moderately complex manufacturing operations in classified environments.
• Maintain on-floor presence to support production and ensure compliance.
• Perform batch record reviews and verify documentation accuracy.
• Review manufacturing records and environmental monitoring data.
• Execute and verify line clearance activities.
• Escalate complex or high-risk issues as needed.
• Support deviation investigations and CAPA activities.
• Review facility alarms, work orders and return-to-service documentation.
• Participate in audits, inspections, and cross-functional quality initiatives.
• Adhere to gowning, safety, and cleanroom procedures.

Skills

QA experience

cGMP knowledge

Regulatory compliance

Issue resolution

Education

Bachelor’s degree in applied science

Job description

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; 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.

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.