Scientist - Quality Control Specialist

3 days ago

Lebanon, Indiana, United States Eli Lilly Full time
Job Title: Scientist - Quality Control

Lilly is a global healthcare leader dedicated to making life better for people around the world. We are seeking a highly skilled Scientist - Quality Control to join our team in the Quality Control Laboratory.

Job Summary:

The Scientist - Quality Control will be responsible for conducting precise and prompt testing of laboratory samples, adhering to applicable GMP and safety standards. This role requires proficiency across multiple domains, including Bioassay, product testing Microbiology, and Chemistry.

Key Responsibilities:
  • Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.
  • Use technical knowledge in the review and interpretation of data for conformance to procedures, standards, and protocols.
  • Second Person Verify (SPV) of analytical data generated in the laboratory.
  • Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
  • Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Troubleshoot equipment and methods as required.
  • Assist in improvement of quality systems by creating or revising lab documentation systems.
  • Share technical information and best practice within plant sites or group.
  • Perform routine equipment standardizations through execution of well-defined protocols.
  • Identify and communicate opportunities for improvement initiatives in daily work activities.
  • Review SOPs for executable as written.
  • Comply with and implement safety standards.
  • Execute notification to management when required by procedures or standards.
  • Recognize when a deviation from procedures has occurred and initiates and participates in a Root Cause Investigation.
  • Train and mentor others. Develop training materials.
Requirements:
  • A bachelor's degree (4-year college) in a related scientific field (Biology, Biochemistry, Chemistry, Microbiology, etc.)
  • 3+ years of experience in Pharma QC labs
  • Must pass eye exam and not be color blind
Preferred Qualifications:
  • Demonstrate strong math and documentation skills.
  • Demonstrate strong oral and written communication and interpersonal interaction skills.
  • Proficiency with computer systems including Microsoft Office products, LIMS, and etc.
  • Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
  • Strong understanding of regulatory standards/requirements for a GMP Laboratory.
  • Experience with some or all of the following analytical techniques: ddPCR, qPCR, HPLC (SEC, IEX, RP, etc.), CE-SDS, ELISA, Cell Culturing, Endotoxin, Bioburden, Growth Promotion, Sterility Testing, Sub-visible Particulates, Wet Chemistry, and CCIT.
Additional Information:
  • May be required to perform testing to support manufacturing during off hours on a rotating schedule.
  • Applicant will work in various areas within the LP2 site. Some allergens are present in the site and Laboratory. Mobility requirements and exposure to allergens should be considered when applying for this position.
  • Tasks may require repetitive motion (e.g., keyboarding, pipetting, plating, etc.).

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.

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