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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
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 Associate provides assistance and guidance in deviation investigations, change control proposals, procedure and master production revisions, validations and batch dispositions. The QA Associate’s position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.
- 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 with relevant work 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:
- Must complete Learning Plan for Associate – QA – IAPI.
- No certifications required.
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
- Must support 24 hour/day operations.
The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
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: 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, Working and Living with Disabilities. Learn more about all of our groups.
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 Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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