QA Manager

Role Summary: The Site Quality Assurance Manager (Site QA) plays a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of PET 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 PET quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, PET 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.

Ideally, there will be separation of QA functions from production and QC functions. However, depending on the size of the facility, these activities may be performed by the same person if there is the ability to segregate batch release from production through appropriate cross-training for batch release. For smaller facilities, the site QA may assume other duties which may include production activities, operation of the facility's cyclotron and associated chemistry modules and analytical equipment for production and QC of PET radiopharmaceuticals. The position may be required to perform various radiation safety and quality related tasks as directed by management.

Job Responsibilities and Duties:

• Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety.
• Actively promote adherence to SOPs, as well as safety rules and awareness. Report and take initiative to correct safety & 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 cGMP environment; May perform aseptic processing related tasks.
• Responsible for quality assurance oversight of routine production, packaging and shipping of radioisotopes.
• Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms to assure that all meet specification; manage onsite inventory quarantine and control process according to SOPs to assure specifications are met. Assure approved vendors used and maintain documents and records, including COA.
• Review batch, laboratory and production records to assure completeness, accuracy and conformance before batch release; authorize or reject batch according to SOPs or oversee batch release by other qualified team members. Perform batch trending analysis.
• Notify facility manager if any recall necessary to assure that recalled materials are not administered to patients. Complaint handling SOP followed.
• Initiate change to SOPs, participate in authoring and review of SOPs, maintain documents under control in QMS. Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management.
• Document and Trend deviations, IRs, events and. Initiate investigation and assure documentation of corrective actions and retraining as applicable. Initiate and complete CAPA investigation as deemed necessary 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. Perform annual retraining upkeep of training files.
• Assure aseptic processing of samples and products, as per SOP. Assure aseptic processing area suitably cleaned, maintained, controlled to prevent mix-ups or contamination; assure personnel qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes used according to SOP. Assure environmental monitoring records are complete and readily available, including annual personnel media fill qualifications.
• Assure equipment is functional, within calibration, suitable for use, maintained and documented per SOP. Assure equipment qualified and operated under specified conditions; maintain vendor IQ/OQ and site PQ documents.
• Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies reported to PharmaLogic Quality and Regulatory.
• Maintain records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management.
• Site lead for FDA and other agency, vendor and internal quality audits, as directed. Maintain site audit readiness by thorough records, personnel, and facility review.
• Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review. Draft ANDA related documents for submission including annual reports and other updates as required.
• Conduct periodic and annual quality audits, training, SOP review and other activities as directed.
• Other duties, if training and qualification are documented; related duties as assigned.

Job Requirements Skills Education:

• BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 3-5 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience. Pharmacy tech certification a plus; experience with aseptic technique.
• Experience working with ionizing radiation and laboratory equipment desirable including troubleshooting and repairs.
• Strong analytical, critical thinking and customer service skills. Experience working on a cross-functional team in fast-paced environment.
• Strong knowledge of cGMP environment and regulations. Knowledge of CFR21 Part 212 preferred.
• Strong attention to detail and experience with managing multiple projects and priorities.

Physical and Intellectual Requirements: Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs.; ability to write SOPs and organize projects, analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational and communication skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.