Supervisor - QC - IAPI
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Enforce compliance accurately and safely to all procedures, methods, related support activities and other regulatory commitments.
- May oversee performance of data entry and review and verify (SPV) data generated by lab analysts for accuracy in accordance with laboratory procedures, standards, and GMP requirements as necessary.
- Recognize when a deviation from procedures, methods, etc. has occurred and initiate a deviation in Trackwise
- Maintain a high-level understanding of the analytical laboratory process.
- Ensure Laboratory inspection readiness.
- Assist with troubleshooting equipment and methods as required.
- Participate and perform investigations as required.
- Identify and communicate opportunities for improvement initiatives in daily work activities (5S, PDCA, A3s, and Gembas)
- Share technical information and best practice within area.
- Participate and/or lead laboratory projects in adherence to Lean OpEx standards.
- Assist with mentoring others within the laboratory.
- Initiate Change controls and Deviations as required.
- Proactively manage day-to-day deliverables.
- Provide quality and timely customer service and communicate with operations as the In Process lab liaison.
- Identify and resolve safety issues and escalate through the BeSafe system.
- Conduct thorough shift changes and ensure awareness of all issues with sample testing, analysis and equipment troubleshooting.
- Work with respective Sr Manager/Associate Director to assure adequate analyst coverage due to vacations/illnesses to provide timely customer service.
- Provide leadership for IAPI In Process work groups as well as to Process Teams performing off hour testing support for operations (BCA Swabs, Raw Materials, etc.).
- Ensure individual/staff Leaning Plan is maintained current.
- Ensure Wellnomics (Workpace) adherence – reduce medium and high risk.
- Follow and ensure adherence with vacation and absence policies.
- Align Performance Management plans of direct reports with the goals and objectives of the department and corporate business priorities.
- Facilitate Performance Management of direct reports and contribute to the Performance Management for reports of respective M1/M2 in In-Process lab.
- Responsible for employee development objectives and career planning.
- Provide ongoing feedback, coaching, mentoring, and assessment of direct reports throughout the year.
- High School diploma/GED equivalent, completion of the required exams or simulations, and authorization to work in the United States without employment visa sponsorship.
- Associates degree (2 yr. College degree) in a science field related to the laboratory in which they are placed (e.g., chemistry for chemistry laboratory or micro or biology for micro laboratory) or 5+ years of demonstrated relevant experience in a GMP (analytical chemistry or microbiology) laboratory.
- Proficiency with computer systems including Microsoft Office products, LIMS, SmartLab, Empower, etc.
- Ability to work in a laboratory environment, including wearing appropriate PPE and other safety required equipment and considerations.
- Ability to work in a highly regulated environment.
- Demonstrated strong math and documentation skills.
- Demonstrated strong oral and written communication and interpersonal interaction skills.
- Previous laboratory experience.
- Previous experience with Lilly deviation and change control process.
- Must complete appropriate Learning Plan curricula for Supervisor – QC – IAPI.
- Must be able to lift at least 5 liters of liquid.
- Tasks may require repetitive motion and standing for long periods of time.
- Some overtime will be required to provide Leader/analyst coverage for vacations/illnesses.