On-Site Night QA Specialist — Radiopharmaceuticals

PHARMALOGIC HOLDINGS; Pittsburgh (Allegheny County); On-site; USD 50,000 - 60,000; Full time

Job summary

PharmaLogic is seeking an On-Site QA Specialist to ensure cGMP compliance and oversee quality activities for PET radiopharmaceutical production at the Pittsburgh site. The role includes batch release, QC, environmental monitoring, CAPA, QA audits, and regulatory readiness, with a night shift from 10:00 PM to 6:00 AM.

A BS/BA in a relevant science and 1–3 years QA experience are required. This fast‑growing radiopharmaceutical CDMO offers opportunities for professional growth and a collaborative,

Qualifications

• BS/BA degree in a relevant scientific discipline with 1–3 years QA experience.
• Pharmacy tech certification a plus; aseptic technique experience a plus.
• Strong knowledge of cGMP regulations and radiation safety.
• Experience with ionizing radiation and laboratory equipment desirable.

Responsibilities

• Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety.
• Oversee production operations to assure PET drugs meet identity, strength, quality and purity.
• Review batch, laboratory and production records for completeness and conformance before batch release.
• Assist in conducting periodic and annual quality audits and maintain audit readiness.
• Support FDA inspections and maintain documentation and training records.

Skills

Quality experience

cGMP knowledge

Radiation safety awareness

Analytical thinking

Education

BS/BA in relevant scientific discipline

Job description

PharmaLogic is seeking an On-Site QA Specialist to ensure cGMP compliance and oversee quality activities for PET radiopharmaceutical production at the Pittsburgh site. The role includes batch release, QC, environmental monitoring, CAPA, QA audits, and regulatory readiness, with a night shift from 10:00 PM to 6:00 AM.

A BS/BA in a relevant science and 1–3 years QA experience are required. This fast‑growing radiopharmaceutical CDMO offers opportunities for professional growth and a collaborative,