QA Manager

Pharma Logic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radio pharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

Pharma Logic offers you an exceptional opportunity to join our dynamic team as a Quality Assurance Manager!

If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.

QA Manager (1am to 2am start times; some shifts are 9am to 5 pm)

As the site Quality Assurance Manager, you will play a vital role in the Pharma Logic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients. Responsible for completion of required quality assurance tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET quality assurance.

The position involves a hands‑on role in all quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, drug quality control, sterility, environmental monitoring, equipment maintenance/qualification/calibration, investigation (IR, OOS, deviation, etc.) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity, ANDA documentation and other routine QA functions. The site QA is responsible for training documentation for the staff on QA related activities.

The site QA is the responsible person for FDA inspections at the site and is listed on the FDA filing and associated permits as applicable.

• Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety.
• Actively promote adherence to SOPs, safety rules and awareness; report and take initiative to correct safety and environmental hazards.
• Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&R as necessary.
• Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity.
• May perform PET radiopharmaceutical Quality Control (QC) in a cGMP environment.
• May perform aseptic processing related tasks.
• Responsible for quality assurance 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 to assure all meet specifications; manage onsite inventory quarantine and control process according to SOPs.
• Assure approved vendors are used and maintain documents and records, including COA.
• Review batch, laboratory and production records to ensure completeness, accuracy and conformance before batch release; authorize or reject batch or oversee batch release by other qualified team members.
• Perform batch trending analysis.
• Notify facility manager if any recall is necessary to assure that recalled materials are not administered to patients.
• Initiate changes to SOPs, participate in authoring and review, maintain documents under control in QMS; assure SOPs match processes and procedures in PET manufacturing and report concerns to Management.
• Document and trend deviations, IRs, events and initiate investigations; assure documentation of corrective actions and retraining as applicable.
• Initiate and complete CAPA investigations as needed and report results and trends.
• Maintain facility compliance with environmental monitoring and aseptic control; review and trend environmental monitoring results and all testing records.
• Provide training to staff on QA activities and SOPs; assure staff is qualified for assigned quality tasks with documentation of training and qualification.
• Maintain records for inspection and perform annual retraining upkeep of training files.
• Assure aseptic processing of samples and products as per SOP; assure…