Quality Assurance Specialist

About the role

PharmaLogic is seeking an on‑site Quality Assurance Specialist to support its fast‑growing PET radiopharmaceutical operations. The role ensures compliance with cGMP, radiation safety and other regulatory standards for the manufacture and release of PET drugs.

Key responsibilities

• Maintain compliance with cGMP, radiation safety, and company SOPs.
• Oversee material acceptance, quarantine, batch release, and record review.
• Perform PET drug quality control, including sterility and environmental monitoring.
• Manage equipment qualification, calibration, and maintenance.
• Lead investigations of incidents, OOS, deviations and drive CAPA actions.
• Write, maintain and review SOPs; ensure inspection readiness.
• Ensure data quality, integrity and proper ANDA documentation.
• Act as the primary contact for FDA inspections and related filings.

Required profile

• Experience in cGMP environments, preferably within radiopharmaceutical or pharmaceutical manufacturing.
• Strong understanding of PET drug production processes and regulatory requirements.
• Ability to work independently while coordinating with production, QC and management teams.
• Excellent documentation and investigative skills.

Required skills

• cGMP compliance
• PET radiopharmaceutical quality control
• Aseptic processing
• Equipment qualification and calibration
• Radiation safety procedures
• Investigation of incidents (IR, OOS, deviations)
• CAPA implementation
• SOP writing and maintenance
• Inspection readiness
• Data quality and integrity
• ANDA documentation