Quality Assurance Specialist

PharmaLogic•San Juan, PR - 2PRS, San Juan, PR, PR, PR

12d•Onsite

About The Position

PharmaLogic is a radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. The Quality Assurance Specialist works on-site as part of PharmaLogic’s quality program, assuring compliance with cGMP and other standards for manufacturing PET drugs for administration to patients. The role completes quality assurance tasks for finished drug products as directed by cGMP SOPs and serves as the site’s PET quality assurance expert. The position covers hands-on site QA functions, including materials acceptance and quarantine, batch release and record review, PET drug quality control, sterility, environmental monitoring, equipment maintenance, qualification and calibration, investigations and CAPA, SOP management, inspection readiness, data quality and integrity, ANDA documentation, and other routine QA work. The specialist is the responsible person for FDA inspections at the site and is listed on applicable FDA filings and permits. QA duties may need to be combined with production or QC activities depending on facility size, with batch-release responsibilities appropriately segregated. At smaller facilities, duties may also include production, operation of the cyclotron and associated chemistry modules and analytical equipment, and radiation safety and other quality-related tasks as directed by management. The posting gives conflicting schedule descriptions: 10:00 pm to 6:00 am, 2:00 am to 12:00 pm in rotating 8-hour shifts, and 2:00 am to 12:00 pm in 8-hour shifts. It states 40 hours per week.

Requirements

Bachelor of Science or Bachelor of Arts degree in a relevant scientific discipline, such as chemistry, physics, nuclear pharmacy, nuclear medicine, or engineering, and 3–5 years of pharmaceutical-industry quality experience, or an equivalent combination of education and experience; the posting describes this as preferred.
Strong analytical, critical-thinking, and customer-service skills.
Experience working on a cross-functional team in a fast-paced environment.
Strong knowledge of cGMP environments and regulations.
Strong attention to detail and experience managing multiple projects and priorities.

Nice To Haves

Pharmacy technician certification.
Experience with aseptic technique.
Experience working with ionizing radiation and laboratory equipment, including troubleshooting and repairs.
Knowledge of CFR 21 Part 212.

Responsibilities

Ensure compliance with regulatory commitments, company policies, SOPs, cGMP, and radiation-safety requirements.
Promote adherence to SOPs and safety practices; report and take initiative to correct safety and environmental hazards.
Promptly notify the site Manager, PET Operations Management, and Q&R of quality-related issues as necessary.
Oversee production operations to ensure PET drugs meet requirements for identity, strength, quality, and purity.
Perform PET radiopharmaceutical QC and, where assigned, aseptic-processing tasks.
Provide QA oversight of routine production, packaging, and shipping of radioisotopes.
Examine and approve or reject components, closures, in-process materials, packaging materials, labeling, and finished dosage forms; manage onsite inventory quarantine and control; ensure approved vendors are used and maintain supporting documents and records, including certificates of analysis.
Review batch, laboratory, and production records for completeness, accuracy, and conformance before batch release; authorize or reject batches or oversee release by qualified team members; perform batch trending analysis.
Notify the facility manager when a recall is necessary and follow complaint-handling procedures.
Initiate, author, and review SOP changes; maintain controlled documents in the QMS and ensure SOPs reflect PET manufacturing processes and procedures.
Document and trend deviations, IRs, and events; initiate investigations; ensure corrective actions and retraining are documented; initiate and complete CAPA investigations as necessary and report results and trends.
Maintain environmental monitoring and aseptic controls; review and trend environmental-monitoring results and testing records.
Train staff on QA activities and SOPs; ensure personnel are qualified for assigned quality tasks and maintain training, qualification, and inspection records, including annual retraining files.
Ensure aseptic processing of samples and products; maintain suitably cleaned and controlled aseptic areas; ensure personnel are qualified in aseptic technique and area cleaning; ensure approved cleaning agents and processes are used and environmental-monitoring records, including annual personnel media-fill qualifications, are complete and available.
Ensure equipment is functional, calibrated, suitable for use, maintained, documented, qualified, and operated under specified conditions; maintain vendor IQ/OQ and site PQ documents.
Ensure master production, laboratory control, analytical-test, and other control records match actual procedures, and report discrepancies to PharmaLogic Quality and Regulatory.
Maintain FDA- and SOP-compliant records; monitor and report on the site's QA program to management.
Lead site FDA, other agency, vendor, and internal quality audits as directed; maintain audit readiness through review of records, personnel, and facilities.
Maintain the site's ANDA and related filing documentation, and draft ANDA documents for submission, including annual reports and updates.
Conduct periodic and annual quality audits, training, SOP review, and other directed activities.
Perform other related duties as assigned when training and qualification are documented.