Biologist - Quality Control

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. Were looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

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

Responsibilities:

• 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 for 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.

• Verify (SPV) analytical data of other analysts within the lab as requested.

• May perform holistic review of data for release of data from the laboratory.

• Recognizes when a deviation from procedures 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 creating or revising worksheets and other lab documentation systems.

• Identifies and communicates opportunities for improvement initiatives in daily work activities.

• Reviews SOPs for executable as written.

• Shares technical information and best practice within plant sites or group.

• Write protocols for non-routine testing or validation with appropriate guidance.

• Perform routine equipment calibrations or maintenance through execution of well-defined protocols.

• Comply with and implement safety standards.

• Executes notification to management when required by procedures or standards.

• Initiate change controls and deviations.

• Train and mentoring others. Develop training materials.

Basic Qualifications:

• Bachelor's degree in scientific field related to the lab (Biology/Microbiology/Biochemistry).

• At least 2 years laboratory experience in GMP QC Laboratory environment.

Additional Preferences:

• Endotoxin, sterility, or growth promotion testing.

• Proficiency with computer systems including Microsoft Office products, LIMS 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.

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Information:

• 8 hour days Monday through Friday

• Minimal travel required.

• Ability to cover weekends, holidays, and company shutdowns as needed.

• 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).

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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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