Biologist-QC Micro - Eli Lilly and Company

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.

The Biologist performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. They complete second person verification of others results. The Biologist also assists in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by performing well-defined protocols and procedures. The Biologist also shares technical information and best practices within plant sites or group.

Responsibilities:

• Verify (SPV) analytical data of other analysts within the lab as requested.
• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data ensuring conformance to procedures, standards and protocols and/or real-time recognition of aberrant data and results.
• Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements.
• May perform comprehensive review of data for release of data from the laboratory.
• Recognizes when a deviation from procedures, etc has occurred and initiates and participates in a Root Cause Investigation.
• Performs investigations for deviations.
• Troubleshoot equipment and methods as required.
• Assist in improvement of quality systems by crafting or revising worksheets and other lab documentation systems.
• Evaluates and communicates opportunities for improvement initiatives in daily work activities.
• Contribute to development of PQEs.
• Reviews SOPs for executable as written.
• Shares technical information and best practices within plant sites or group.
• Write protocols for non-routine testing or validation with appropriate guidance.
• Develops equipment qualification protocols with appropriate guidance.
• Perform routine equipment calibrations or maintenance through execution of well-defined protocols.
• Adhere to and implement safety standards.
• Communicates notification to management when required by procedures or standards.
• Initiate change controls and deviations.
• Train and mentoring team members. Develop training materials.

Basic Qualifications:

• Bachelor (4 yr College) degree required. Degree in a STEM field, Biology or Microbiology preferred.
• 2 years of experience in GMP facility.

Additional Preferences:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Proficiency with computer systems including Microsoft Office products, LIMS (list other lab systems), etc.
• Ability to working in a lab environment including wearing appropriate PPE and other safety required equipment and considerations.
• Demonstrated strong math and documentation skills.
• Demonstrated strong oral and written communication and interpersonal interaction skills.

Additional Information:

• 8 hour days – Monday through Friday
• Required to wear a pager off shift and respond to operational issues.
• Minimal travel required.
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position
• Tasks may require repetitive motion (e.g., keyboarding).
• Post-offer testing exam may be required.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 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.

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