On-Site Night QA Lead, PET Radiopharma

PharmaLogic; San Juan (PR); Sur place; USD 75 000 - 110 000; Plein temps

Avantages offerts par ce poste

401(k)

Medical insurance

Dental care

Disability insurance

Employee assistance program

Extended health care

Life insurance

On-site parking

Paid time off

Vision care

Résumé du poste

PharmaLogic is seeking an On-Site Quality Assurance Specialist to support the QA program for PET drug manufacture. The role requires ensuring compliance with cGMP, QA activities, and regulatory expectations at the site.

The position involves hands-on QA duties including materials acceptance, batch release, investigations, CAPA, and SOP maintenance, with the QA lead role for FDA inspections.

Qualifications

• BS/BA degree in a relevant scientific discipline and 3–5 years of QA experience in the pharmaceutical industry.
• Pharmacy tech certification is a plus; aseptic technique experience preferred.
• Experience with ionizing radiation and laboratory equipment is desirable.
• Strong knowledge of cGMP and CFR Title 21 Part 212 is required or strongly preferred.
• Excellent attention to detail and ability to manage multiple projects simultaneously.

Responsabilités

• Ensure compliance with all regulatory commitments, cGMP, and radiation safety through SOP adherence.
• Oversee batch release and record review to verify PET drug identity, strength, quality and purity.
• Review and investigate deviations, IRs, CAPA, and environmental monitoring results; implement corrective actions.
• Prepare for and support FDA inspections; maintain inspection readiness and audit trails.
• Provide training on QA activities and SOPs; maintain training records and qualifications.
• Maintain site QA documentation, QMS records, and ensure proper documentation control.

Connaissances

Analytical thinking

Critical thinking

Customer service

Quality assurance

Formation

BS/BA in a scientific discipline

Description du poste

PharmaLogic is seeking an On-Site Quality Assurance Specialist to support the QA program for PET drug manufacture. The role requires ensuring compliance with cGMP, QA activities, and regulatory expectations at the site.

The position involves hands-on QA duties including materials acceptance, batch release, investigations, CAPA, and SOP maintenance, with the QA lead role for FDA inspections.