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Supervisor – QC– IAPI

Supervisor: Associate Director – QC – IAPI
Position Title: Supervisor – QC– IAPI
Position Type: Full Time (Night Shift)
Job Level: B5
Location: LTC – South
Job Function: Quality Control
Tech Ladder Approved: No

Position Brand Description:

The Supervisor – QC – IAPI position provides leadership and technical abilities to support the advancement of laboratory process knowledge/optimization, performance planning, and compliance. The Supervisor – QC – IAPI also completes tasks to support an area’s daily workload, may contribute to laboratory testing and second person verification activities, and provides shift direction and communication as a liaison between the lab and operations. They will perform these tasks all while developing employees. This position adheres to a night shift (3-2-2-3) schedule that provides direct manufacturing support as part of the IAPI In-Process Laboratory.

Key Objectives/Deliverables:

Sample Analysis and Reporting

• 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.

Continuous Improvement

• 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 Op Ex standards.

Laboratory Operations

• 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 Be Safe 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.

People

• 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.

Basic Requirements:

• 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, Smart Lab, 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.

Additional Preferences:

• Previous experience with Lilly deviation and change control process.

Other Information:

• 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.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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