Associate - QA API EM
Eli Lilly and Company
2 hours ago
On-site
Indianapolis, IN
Operations
Key Objectives/Deliverables
- Serve as a liaison between Contract Manufacturing organizations (CMs) and Lilly.
- Provide quality oversight of QC activities at CMs; act as initial point of contact for quality issues with testing.
- Provide quality oversight of CM method validation/method transfer.
- Escalate CM quality issues to Lilly QA management.
- Assist with establishment/revisions of Quality Agreements; ensure compliance to Quality Agreements and MRDs.
- Coordinate/perform quality responsibilities for API shipments for stability testing; oversee API EM stability program.
- Prepare for regulatory inspections with CMs.
- Ensure documented checks for CoTs/Certificates of Environmental Monitoring (if applicable), deviations, changes, and batch documentation prior to batch release.
- Support holistic review of QC-impacting deviations, change controls, and countermeasures.
- Review impacts of analytical deviation investigations/changes; ensure records are documented/retrievable.
- Maintain awareness of external regulatory findings affecting product quality.
- Review/approve analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods, and computerized system validations.
- Participate in APR, productivity improvement projects, JPT, and PLOT.
Basic Requirements
- BS in a science-related field.
- 5+ years GMP QC laboratory knowledge/experience in API or finished product manufacturing, QA, or Engineering.
- Authorization to work in the US full-time; no visa/work authorization sponsorship.
Additional Preferences
- Small molecule testing; quality-system/regulatory knowledge; pharmaceutical manufacturing operations; coaching/mentoring; root cause analysis; statistics; strong written/verbal communication; attention to detail; computer proficiency; interpersonal/networking; prioritize multiple tasks; influence/manage relationships.
Other Information / Benefits
- Complete required API EM Quality Assurance training; no certifications required.
- Wear PPE in manufacturing/lab areas; support 24/7 operations; up to 20% travel US & OUS.
- Bonus eligibility for FTEs (performance-dependent) and comprehensive benefits (e.g., 401(k), medical/dental/vision, vacation, life/disability and well-being).
- Serve as a liaison between Contract Manufacturing organizations (CMs) and Lilly.
- Provide quality oversight of QC activities at CMs; act as initial point of contact for quality issues with testing.
- Provide quality oversight of CM method validation/method transfer.
- Escalate CM quality issues to Lilly QA management.
- Assist with establishment/revisions of Quality Agreements; ensure compliance to Quality Agreements and MRDs.
- Coordinate/perform quality responsibilities for API shipments for stability testing; oversee API EM stability program.
- Prepare for regulatory inspections with CMs.
- Ensure documented checks for CoTs/Certificates of Environmental Monitoring (if applicable), deviations, changes, and batch documentation prior to batch release.
- Support holistic review of QC-impacting deviations, change controls, and countermeasures.
- Review impacts of analytical deviation investigations/changes; ensure records are documented/retrievable.
- Maintain awareness of external regulatory findings affecting product quality.
- Review/approve analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods, and computerized system validations.
- Participate in APR, productivity improvement projects, JPT, and PLOT.
Basic Requirements
- BS in a science-related field.
- 5+ years GMP QC laboratory knowledge/experience in API or finished product manufacturing, QA, or Engineering.
- Authorization to work in the US full-time; no visa/work authorization sponsorship.
Additional Preferences
- Small molecule testing; quality-system/regulatory knowledge; pharmaceutical manufacturing operations; coaching/mentoring; root cause analysis; statistics; strong written/verbal communication; attention to detail; computer proficiency; interpersonal/networking; prioritize multiple tasks; influence/manage relationships.
Other Information / Benefits
- Complete required API EM Quality Assurance training; no certifications required.
- Wear PPE in manufacturing/lab areas; support 24/7 operations; up to 20% travel US & OUS.
- Bonus eligibility for FTEs (performance-dependent) and comprehensive benefits (e.g., 401(k), medical/dental/vision, vacation, life/disability and well-being).