Specialist - QC-AESG- IAPI

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 35,000 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.

Organization Overview:

The Specialist - 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 Specialist - QC-AESG - IAPI may also contribute to general maintenance, laboratory testing, validation activities, and second person verification activities.

Responsibilities:

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
• 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:

• 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
• Experience within a regulated industry; FDA regulated industries preferred
• Previous laboratory or analytical maintenance experience
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• One year of (Process) experience

Additional Skills/Preferences:

• Ability to perform quality work without close supervision
• Proficiency in CMMS (e.g., GMARS), Microsoft Word, and Microsoft Excel.
• Experience in providing a high-level of customer service
• Ability to follow written procedures while performing maintenance activities
• Ability to work in team environment.
• Track record of maintaining a neat and orderly work area (good housekeeping).
• Demonstrated knowledge of troubleshooting process related equipment failures
• Good documentation practices and communication skills (both written and verbal)
• Demonstrated record of maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Willingness to work outside of your craft, as required
• Proficiency with computer systems including Microsoft Office products, LIMS, etc.
• 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

Additional Information:

• Must be willing to work overtime during peak periods (e.g. monthly shutdowns, etc.). Schedule could change due to business needs for additional coverage during Shutdowns, training and peak vacation times.
• The applicant will be required to respond to off-hour or weekend call-in emergencies when necessary.
• Individual must be able to comply with all building gowning and SOP requirements and be expected to perform in various areas within manufacturing
• US travel requirements are 5% or less.

Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

#WeAreLilly