QA Manager – PET Radiopharmaceuticals Compliance Lead

PharmaLogic; Austin (TX); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

PharmaLogic is seeking a Quality Assurance Manager to lead the site quality program, ensuring cGMP compliance for PET radiopharmaceuticals. The role involves hands-on QA duties across batch release, quality control, environmental monitoring, calibration, and CAPA with cross-training to support production as needed.

The site QA serves as the FDA-inspected responsible person and drives training, SOP maintenance, and inspection readiness.

Qualifications

• BS/BA degree in a relevant scientific discipline and 3–5 years QA experience.
• Experience with aseptic technique a plus; knowledge of CFRs preferred.
• Strong analytical and communication skills.
• Familiarity with cGMP environment and FDA inspections.

Responsabilités

• Ensure compliance with cGMP, SOPs, and radiation safety.
• Oversee batch release, record review, and environmental monitoring.
• Lead CAPA investigations and change control activities.
• Train staff on QA activities and maintain training records.
• Prepare for and participate in FDA inspections and audits.
• Maintain QA documentation and audit readiness.

Connaissances

Quality assurance

cGMP

SOP writing

CAPA management

FDA inspections

Formation

BS/BA in science or related field

Description du poste

PharmaLogic is seeking a Quality Assurance Manager to lead the site quality program, ensuring cGMP compliance for PET radiopharmaceuticals. The role involves hands-on QA duties across batch release, quality control, environmental monitoring, calibration, and CAPA with cross-training to support production as needed.

The site QA serves as the FDA-inspected responsible person and drives training, SOP maintenance, and inspection readiness.