AmerisourceBergen Corporation Laboratory Quality Director in LAKE FOREST, Illinois
Title: Laboratory Quality Director Location: United States-Illinois-Lake Forest Job Number: 00001TKA
This position will report to the VP of Quality at PharMEDium. The Director of Laboratory Quality is responsible for the overall oversight of methodology, techniques, CAPAs, and process in the Quality Control Laboratories. The Director must have a high level knowledge of chemistry testing, microbiological testing techniques/methodology, laboratory automation, and aseptic techniques in the sterile pharmaceutical manufacturing, environmental monitoring, and applicable FDA guidance, and 21 CFR parts 210, 211.
• Provide leadership, strategic thinking and oversight towards the establishment, management, growth and oversight of all QC Laboratories at PharMEDium. • Collaborate with Subject Matter Experts and key stakeholders to build QC Chemistry and Microbiological laboratory, qualify instrumentation, author SOPs that support release of incoming drug materials and drug products. • Collaborate with key stakeholders on management of analytical method validation, transfer and troubleshooting of key methods utilized in QC laboratories. • Manage all contract laboratories performing quality control testing. • Participate in regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits • Facilitate audits of existing and new contract laboratories Qualifications: 1. M.S. or higher degree in Chemistry/Microbiology/Biology/Biochemistry or related science with a minimum of 10 years of GMP pharmaceutical aseptic practices, and 7 significant years of leadership of multiple staff members and teams. Experience leading remote teams is a plus. 2. Experience in a FDA regulated laboratory industry. 3. Experience with compendia chemistry method, microbiological methods, alternative microbiological methods, microbiological identification techniques, environmental monitoring, and aseptic techniques used in sterile fill operations. 4. Experience working with external contract labs is a plus. 5. Experience with participating in FDA and other regulatory authority audits. 6. Experience with a fast-paced laboratory testing for pharmaceutical product release.
Additionally: 1. Actively participate in audits (internal and regulatory) with independent close out of observations 2. Effective organization and planning skills 3. Excellent technical and verbal skills 4. Must have the ability to multi-task 5. Have problem solving skill set 6. Knowledge of computerized data collection systems 7. Understanding and experience utilizing the Compendial methods 8. Advanced Knowledge and training of microbiological organism identification and GMP documentation of experiments 9. Ability to travel up to 20% Job: Quality Assurance Jobs