Onsite QA Manager — cGMP & Radiopharmacy

PharmaLogic; Pittsburgh (Allegheny County); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

401(k) retirement benefit 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 on site, ensuring cGMP compliance for radiopharmaceutical production and related activities. The role includes batch release, investigations, CAPA, and regulatory readiness.

Responsibilities span supplier oversight, documentation, training, and maintenance of QA systems, with direct reporting to the PET Facility Manager and dotted line to the PharmaLogic PET Quality & Regulator.

Qualifications

• BS/BA degree in a relevant scientific discipline, plus 3-5 years of Quality experience in pharma.
• Pharmacy tech certification a plus; aseptic technique a plus.
• Strong knowledge of cGMP and CFR21 Part 212 preferred.

Responsibilities

• Ensure compliance with cGMP, SOPs, and radiation safety.
• Oversee batch release, investigations, CAPA and deviations.
• Maintain audit readiness and QA documentation up to date.
• Train staff and ensure qualification for QA tasks.
• Coordinate with FDA/agency audits as site lead.

Skills

Analytical thinking

Critical thinking

Customer service

Attention to detail

Cross-functional teamwork

Education

BS/BA in a relevant scientific discipline

Pharmacy tech certification (a plus)

Job description

PharmaLogic is seeking a Site Quality Assurance Manager to lead the QA program on site, ensuring cGMP compliance for radiopharmaceutical production and related activities. The role includes batch release, investigations, CAPA, and regulatory readiness.

Responsibilities span supplier oversight, documentation, training, and maintenance of QA systems, with direct reporting to the PET Facility Manager and dotted line to the PharmaLogic PET Quality & Regulator.