Sr Specialist-Compliance-IAPI (AESG)

Job Details
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
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
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.
#WeAreLilly
Company
Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.
Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States
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