AmerisourceBergen Corporation Senior Manager, Laboratory Process Improvement & Automation (LPIA) in LAKE FOREST, Illinois
Title: Senior Manager, Laboratory Process Improvement & Automation (LPIA) Location: United States-Illinois-Lake Forest Job Number: 00001Q2J
This position will report to the Sr. Director of Quality at PharMEDium. The Sr. Manager of LPIA is responsible for • The implementation and performance of new validated methods/methodology, • Performance, capability, and improvement of laboratory software platforms (LIMS, Empower, ELN). • evaluation and improvement of laboratory processes at all four centers • Transfer of methodology to compounding centers to support compounding activities and to ensure common methods are used across each center. • Directing the activities laboratory Software Application Administrators. • Establishing and maintaining the KPIs of laboratory performance across the centers. The Sr. Manager must have a high level knowledge of both chemistry and microbiological methods, working knowledge of software platforms used in GMP Quality Control Laboratories, understanding of sterile pharmaceutical manufacturing, microbiological techniques, environmental monitoring, applicable FDA guidance, and 21 CFR parts 210, 211 and Part 11.
• Oversee development and implementation and performance of laboratory software applications such as LIMS, ELN, and Empower. Ensure staff receive the appropriate training for the software applications and that site laboratories are utilizing the applications according to PharMEDium SOPs. • Develop company-wide key performance indicators (KPI) for the Quality Control Laboratories. Then analyze the KPI data to identify opportunities to optimize laboratories performance and make recommendations to the Quality Leadership team. • Evaluate, initiate, and lead laboratory process improvement projects using LEAN, Six Sigma (DAMIC) or similar techniques • Participate/lead root causes analysis exercises. • Author/Review SOPs as necessary. • Responsible for representing the Quality Organization as needed in internal meetings, audits, visits, and technical calls in the areas of responsibility. • Responsible for representing the Quality organization in the all areas of responsibility. • Builds effective partnerships with department heads to help drive the business toward achieving company objectives. • Embodies PharMEDium’s cultural values and aligns daily actions with department goals and company culture. Qualifications: 1. Bachelor’s degree or higher in Chemistry or Microbiology or related science with a minimum of 10 years of GMP pharmaceutical testing experience, and 7 significant years of leadership of multiple staff members and teams. Experience leading remote teams is a plus. 2. Experience with implementation and control of GMP laboratory software applications. 3. LEAN or Six Sigma Certifications (Experienced Greenbelt with multiple completed projects is a minimum or newly certified Black Belt) 4. Experience in a FDA regulated laboratory industry. 5. Experience with HPLC/UPLC chromatographic method validation and transfers. 6. Demonstrated skills in conducting root cause analysis, FEMA, and implementation of corrective actions. 7. Experience with a fast-paced laboratory testing for pharmaceutical product release.
- Actively participated 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. Computer knowledge of data collection systems 7. Understanding and Experience utilizing the USP Compendia methods 8. Advanced Knowledge and training of microbiological organism identification and GMP documentation of experiments 9. Ability to travel up to 10% Job: Information Technology Jobs