Quality Assurance Manager - On Site

4 days ago - be among the first 25 applicants.

Quality Assurance Manager - On Site

Company: Pharma Logic

Location: Cincinnati, OH

$65,000.00/yr - $90,000.00/yr

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.

We offer an exceptional opportunity to join our dynamic team as a Quality Assurance Manager! This role requires a passion for nuclear medicine and a commitment to patient care while working in a stimulating and dynamic environment.

Position Title: QA Manager (6 am to 2 pm)

• 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 & 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.
• Perform PET radiopharmaceutical Quality Control (QC) in a cGMP environment.
• Perform aseptic processing related tasks.
• Provide 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 per SOPs.
• Assure approved vendors are 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 is necessary to assure that recalled materials are not administered to patients.
• 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 are 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 Pharma Logic Quality and Regulatory.
• Maintain records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management.
• Lead site QA 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.

• BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 3‑5 years of quality experience in the pharmaceutical industry, or an equivalent combination of education and experience. Pharmacy tech certification a plus; experience with aseptic technique a plus.
• Experience working with ionizing radiation and laboratory equipment, including…