Onsite QA Specialist III - cGMP Cell Therapy

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

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.