Quality Control – Biologist/Microbiology

Industry:

Company: 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.

Position Brand Description:

The EM associate assists in the safe, compliant execution of the environmental monitoring (EM) program for the Research Triangle Park Facility for Lilly production areas (a 24/7 operation). This role is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, and acts as a liaison between EM and multiple areas in ownership and/or execution of improvements, projects, and change controls.

Key Objectives/Deliverables:

• Ensure FUME and EM Programs meet or exceed agency guidelines.
• Provide technical guidance to Operations and other support areas regarding FUME and EM matters.
• Compile, review and approve FUME and EM evaluation reports and data review to support batch release.
• Provide technical support for FUME and EM initiatives involving viable, nonviable, personnel monitoring.
• Manage procedural revisions, if needed.
• Proactively drive FUME and EM projects that support operations, sterility assurance initiatives, and regulatory commitments.
• Perform root cause investigation of EM and/or FUME non-conformances.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Requirements:

• Bachelor degree in microbiology or related science
• 3 years of experience in a GMP pharmaceutical laboratory
• 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 this employment position.

Additional Preferences:

• Strong understanding of current internal and applicable external standards for FUME, EM and sterility assurance.
• Problem solving and decision-making skills, with emphasis on data-based decisions, and customer service.
• Strong technical writing skills and proficiency in technical review of documents.
• Experience (3+ years) in Environmental Monitoring and/or Utilities Monitoring.
• Experience with MODA
• Experience with data trending and analysis.
• Experience with Root Cause Analysis

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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.

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