Quality Assurance Professional: Compliance and Process Expert

4 weeks ago

Marquand, Missouri, United States Eli Lilly Full time
Job Description:

At Eli Lilly, we are dedicated to making life better for people around the world. As a global healthcare leader, we are united by our passion to discover and deliver life-changing medicines.

We are seeking a highly skilled Quality Assurance Representative to join our team in Indianapolis, Indiana. This role will play a critical part in ensuring the quality of our products and materials meets the highest standards.

About the Role:

The Quality Assurance Representative will be responsible for providing independent oversight of manufacturing operations to ensure all products and materials meet quality requirements. This includes final batch release of semi-finished products, supporting plant quality leadership in managing key technical, quality, and compliance issues, and providing guidance, coaching, and advice to plant process teams and flow teams on quality and compliance matters.

Key Objectives/Deliverables:

  • Maintain a safe work environment, lead safety initiatives, and work safely and accountably for supporting all HSE Corporate and Site Goals.
  • Perform final batch disposition of semi-finished drug product batches for Indianapolis Parenteral products, ensuring high-quality medicine (GMP Compliance) is released to market in a timely manner.
  • Provide guidance in operational areas to ensure robust Quality Systems and GMP compliance.
  • Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
  • Effectively review/approve GMP documents to ensure quality attributes are met (i.e., deviations, procedures, protocols, specifications, and change controls).
  • Participate in process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
  • Ensure regular presence in operational areas to monitor GMP programs and quality systems.
  • Review/approve RtQs and updates to regulatory submissions for commercial products, as appropriate.
  • Approve regulatory specification updates in the LIMS.
  • Approve the country list in SAP for the semi-finished item codes.
  • Review/approve changes to core labeling of commercial products related to the drug product properties.
  • Review APRs, ensuring the quality of the data analysis and of the conclusions.
  • As needed, participate in review boards and approve (level permitting) deviations, change controls, and complaints.
Coaching/Mentoring:

  • Lead, mentor, and coach site personnel on quality matters associated with the Batch and the Batch Disposition process.
  • Provide technical leadership to key quality matters. Provide direction and coaching regarding major and/or significant deviations and investigations.
  • Coach and mentor quality operations and other functions supporting parenteral manufacturing operations in topics related to quality and GMP compliance, operational excellence, technical documentation, issue resolution, and process monitoring.
  • Support on-boarding and on-going development of technical capability of quality personnel (e.g., Comprehensive Quality Review representatives, QA process team members, etc.).
  • Provide regular communication with QA operations staff and Process Teams to resolve issues or provide advice on product-related issues.
  • Share routine feedback with Operations and Process Teams based on learning from batch reviews to share learning from batch issues and prevent recurrence, explain the 'why' behind batch issues, and to recognize and reinforce areas where Operations is performing well.
Cross-functional, Network, and Customer Interactions:

  • Work within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives.
  • Interact with regulators or other outside stakeholders on quality/compliance issues or in support of internal and external agency audits.
Basic Qualifications:

  • Bachelor's degree in a scientific field (e.g., chemistry, biology, engineering, pharmacy, or similar) with relevant years of experience in the pharmaceutical industry. Preferably 5+ years' experience directly supporting pharmaceutical manufacturing or quality, with experience in parenteral pharmaceutical products.
Salary Range: $120,000 - $150,000 per year, depending on experience, plus a comprehensive benefits package, including health insurance, 401(k) matching, and paid time off.

Location: Indianapolis, Indiana. This role requires working on the second shift (3:00 PM - 11:30 PM) Tuesday to Saturday, with possible off-shift support. Tasks require entering manufacturing areas, which require wearing appropriate PPE.

This position is tech ladder approved.

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.

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 the 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, and Working and Living with Disabilities.

Learn more about all of our groups.

#WeAreLilly

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