Associate/Sr. Associate - QA API

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 Associate – QA – IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The QA Representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production revisions, validations and batch dispositions. The QA Representative’s position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.

Key Objectives/Deliverables:

• Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Provide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues.
• Participate in aberrant data investigations.
• Conduct analytical data review including stability data.
• Disposition API Intermediates and raw materials, as appropriate.
• Provide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems.
• Investigate customer complaints.
• Participate in and/or support recalls, as appropriate.
• Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of the governing standards.
• Participate in and/or lead self-inspection activities.
• Participate in and/or support regulatory inspections and audits.
• Maintain and improve quality systems.
• Assist others in the interpretation of regulatory and corporate requirements.

Basic Requirements:

• BS in Engineering or a science-related field or equivalent experience.
• 2+ years of Quality Assurance experience

Additional Preferences:

• Experience with computer system validation.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Knowledge of cGMPs and quality systems.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.

Other Information:

• This role is based in Indianapolis, IN and is not approved for remote work.

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 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