Quality Assurance Specialist
On-site · San Juan, San Juan, Puerto Rico
Job Summary
On-Site Quality Assurance Specialist responsible for ensuring cGMP compliance and quality for PET radiopharmaceutical manufacturing. Serves as site expert on PET QA, overseeing QA tasks from finished drug product to release, record review, quality control, environmental monitoring, calibration, CAPA, SOP maintenance, inspection readiness, and regulatory documentation. Roles may include participation in production activities and potential operation of cyclotron/analytical equipment; responsible for FDA inspections and maintaining ANDA-related documentation. Key responsibilities include ensuring regulatory commitments, promoting SOP adherence, handling recalls, reviewing batch and lab records, initiating CAPA investigations, maintaining environmental monitoring programs, training staff, and ensuring overall QA readiness. Ideal candidates will have a BS/BA in a relevant science and 3-5 years of QA experience in the pharmaceutical industry, with knowledge of cGMP and regulatory requirements, and experience in environmental monitoring and aseptic processing.
Required Qualifications
- BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.)
- minimum of 3-5 years Quality experience in the pharmaceutical industry
- Pharmacy tech certification a plus; experience with aseptic technique preferred
- Experience with ionizing radiation and laboratory equipment desirable
- Strong analytical, critical thinking and customer service skills
- Experience with cGMP environment and regulations; CFR21 Part 212 preferred
- Attention to detail and ability to manage multiple projects and priorities
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