On-Site QA Manager, PET Radiopharma

ADP, Inc.; Pittsburgh (Allegheny County); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

401(k) retirement program

Medical

Dental care

Disability insurance

Employee assistance program

Extended health care

Life insurance

On-site parking

Paid time off

Vision care

Job summary

PharmaLogic is seeking a Site Quality Assurance Manager to lead the QA program at our Pittsburgh facility, ensuring cGMP compliance, regulatory readiness, and inspection support for PET radiopharmaceutical manufacturing.

The role blends hands-on QA duties with leadership, training staff, overseeing batch release, CAPA, deviations, and environmental monitoring, reporting to the Facility Manager and QA leadership; on-site hours are 6 am to 2 pm.

Qualifications

• BS/BA degree in a relevant scientific discipline and 3–5 years QA experience in pharma
• Strong knowledge of cGMP regulations and radiation safety practices
• Experience with batch release, QA oversight, audits and CAPA processes

Responsibilities

• Ensure compliance with regulatory commitments and SOPs including cGMP and radiation safety
• Oversee production operations to assure PET drug quality and purity
• Review batch, laboratory and production records prior to release; authorize or reject batches
• Lead QA investigations (IRs, OOS, deviations) and CAPA activities
• Train staff on QA activities and maintain training records
• Maintain inspection readiness and ensure documentation is complete and accessible
• Lead FDA and other agency audits as site QA liaison

Skills

Quality Assurance

Regulatory Compliance

cGMP Knowledge

Education

BS/BA in Chemistry or Engineering

Job description

PharmaLogic is seeking a Site Quality Assurance Manager to lead the QA program at our Pittsburgh facility, ensuring cGMP compliance, regulatory readiness, and inspection support for PET radiopharmaceutical manufacturing.

The role blends hands-on QA duties with leadership, training staff, overseeing batch release, CAPA, deviations, and environmental monitoring, reporting to the Facility Manager and QA leadership; on-site hours are 6 am to 2 pm.