Sr Specialist-Compliance-Iapi (Aesg)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Position Brand Description:

The Lead Technician- QC-AESG - IAPI is part of the Analytical Equipment Support Group (AESG) in API QC. This role will provide technical abilities to support equipment in the laboratory, as required. The Lead Technician- QC-AESG - IAPI may also contribute to general maintenance, laboratory testing, validation activities, scheduling and second person verification activities.

Key Objectives/Deliverables:

Equipment Metrology and Reporting:

• Accurately and safely perform equipment maintenance, metrology, or related support activities as per procedure or protocols
• Perform data entry and review own work for accuracy in accordance with procedures, standards, and GMP requirements
• Verify (SPV) analytical data of other analysts within AESG or the laboratory Problem Solving:
• Recognize when deviation from procedures has occurred and initiate appropriate investigation
• Troubleshoot equipment and methods as required (HPLC, GC and UPLC preferred)
• Participate and perform investigations as required

Continuous Improvement:

• Identify and communicate opportunities for improvement initiatives and maintain data integrity in daily work activities
• Share technical information and best practice within area; Develop equipment qualification protocols with appropriate guidance
• Participate and/or lead laboratory projects • Manage own Performance Management
• Train and mentor others within AESG or the laboratory
• Perform routine equipment qualification/calibrations or maintenance through execution of well-defined protocols
• Execute notification to management when required by procedures or standards
• Initiate change controls and deviations as required

Basic Requirements:

• Proficient in GMARS, Binoc, Veeva Docs and Computerized Maintenance Management Systems (CMMS)
• At least 3 years of laboratory experience and 2 years of GMARS Scheduling for PM's, corrective maintenance and outside Vendors
• Knowledge of the Calibry System and Pipette knowledge
• Proficient in Smartlab, NG8, Empower, Gensuite and updating Job Aids
• Knowledge in shipping of Standards and ability to work with other labs outside of IAPI
• Ability to work in a highly regulated environment, including wearing appropriate PPE and other safety required equipment and considerations
• Demonstrated strong math, documentation, oral and written communication, and interpersonal interaction skills
• At least 3 years laboratory experience and 2 years in GMARS Scheduling

Additional Preferences:

• Bachelor's degree in Medical Technology
• Previous experience with Lilly deviation and change control process

Education Requirements:

• Associates Degree (2 year college degree) or equivalent in a science field related to the laboratory in which they are placed (e.g., chemistry for chem. labs or micro or biology for micro lab) or 5+ years of demonstrated relevant experience in a GMP (analytical chemistry or microbiology) laboratory

Other Information:

• Must complete Learning Plan for a Lead Technician- QC-AESG - IAPI
• Tasks may require repetitive motion, lifting of equipment, and standing for long periods of time

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 specifically not described in the job description. As always, supervision should be consulted regarding actual job responsibilities and any

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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$28.12 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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