QA Manager - On Site

PharmaLogic•Austin, TX

10d•Onsite

About The Position

The site Quality Assurance Manager is responsible for supporting PharmaLogic’s quality program and ensuring compliance with cGMP and other standards for drugs manufactured for patient administration. The manager completes required quality assurance tasks for finished drug products in accordance with cGMP SOPs and serves as the site expert on PET quality assurance. This is a hands-on role covering site quality functions, including materials acceptance and quarantine, batch release and record review, drug quality control, sterility, environmental monitoring, equipment maintenance, qualification and calibration, investigations, CAPA, SOP management, inspection readiness, data quality and integrity, and ANDA documentation. The role also oversees QA-related staff training and documentation. The site QA Manager is the responsible person for FDA inspections and is listed on FDA filings and applicable permits. Depending on facility size and staffing, duties may overlap with production, cyclotron and chemistry-module operation, and analytical equipment used for PET production and QC, provided batch-release responsibilities are appropriately segregated. The role may also perform radiation-safety and quality-related tasks as directed by management. The position is on site and scheduled for 9:00 a.m. to 5:00 p.m., 40 hours per week. PharmaLogic describes a competitive compensation package and superior benefits.

Requirements

Bachelor’s 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 (listed 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 21 CFR Part 212.
The stated education and pharmaceutical quality experience are described as preferred.

Responsibilities

Ensure compliance with regulatory commitments, company policies, SOPs, cGMP, and radiation-safety requirements.
Promote SOP adherence and safety awareness; report and take initiative to correct safety and environmental hazards.
Promptly notify site management, PET Operations Management, and Quality & Regulatory of quality-related issues as necessary.
Oversee production operations to ensure PET drugs meet identity, strength, quality, and purity requirements.
Perform PET radiopharmaceutical QC in a cGMP environment and aseptic-processing tasks as needed.
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 inventory quarantine and control according to SOPs.
Ensure approved vendors are used and maintain vendor documents and records, including certificates of analysis.
Review batch, laboratory, and production records for completeness, accuracy, and conformance before release; authorize or reject batches or oversee release by qualified team members.
Perform batch-trending analysis.
Notify the facility manager when a recall may be necessary and help ensure recalled materials are not administered to patients.
Initiate, author, review, and maintain controlled SOPs and documents in the QMS; ensure SOPs reflect PET manufacturing processes and report concerns to management.
Document and trend deviations, IRs, and events; initiate investigations and ensure corrective actions and retraining are documented as applicable.
Initiate and complete CAPA investigations as needed and report results and trends.
Maintain environmental monitoring and aseptic controls; review and trend monitoring results and testing records.
Train staff on QA activities and SOPs, and document staff qualification and training for assigned quality tasks.
Maintain inspection records and conduct annual retraining and training-file upkeep.
Ensure aseptic processing of samples and products; oversee cleanliness, maintenance, and control of aseptic areas, prevention of mix-ups or contamination, personnel qualification, and approved cleaning processes and agents.
Ensure environmental-monitoring records are complete and available, including annual personnel media-fill qualifications.
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 records, laboratory controls, analytical tests, and other control records reflect actual procedures and report discrepancies to PharmaLogic Quality and Regulatory.
Maintain records required by FDA and SOPs; monitor and report on the site QA program to management.
Lead site FDA and other agency, vendor, and internal quality audits as directed, and maintain audit readiness through review of records, personnel, and facilities.
Maintain the site ANDA and related filing documentation; draft ANDA submission documents, including annual reports and updates.
Conduct periodic and annual quality audits, training, SOP reviews, and other directed activities.