Senior Associate-Quality Assurance
Elanco
August 13, 2026
On-site
Clinton, IN
Operations
Senior Associate – Quality Assurance
Responsibilities:
- Provide quality control support for laboratory investigations, Product Quality Reviews (PQR), and method validation.
- Maintain GMP compliance and inspection readiness via periodic audits and inspections of production areas.
- Author and support deviation investigations; implement change control proposals.
- Collaborate with cross-functional QC teams (laboratory technicians, chemists, analysts) to ensure quality standards.
- Investigate customer complaints and review critical quality documents, including validation and PQR.
- Strengthen site Quality Systems by writing/revising SOPs, delivering site training, conducting internal audits, verifying inspection readiness, monitoring quality metrics, and representing the site in corporate knowledge-sharing forums.
Minimum Qualifications:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or related scientific field.
- 2+ years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment.
- Proficiency in cGMP regulations and experience with quality documentation systems.
Preferred Qualifications:
- Experience coaching or providing technical feedback to QC staff.
- Ability to handle non-standard requests and participate in regulatory audits.
- Strong technical writing skills for validation and PQR documents.
- Experience with change control implementation and deviation management.
- Ability to work effectively in cross-functional teams.
Location: Clinton, IN – Onsite Manufacturing Facility
Benefits and Perks:
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus; up to 6% 401K matching.
Responsibilities:
- Provide quality control support for laboratory investigations, Product Quality Reviews (PQR), and method validation.
- Maintain GMP compliance and inspection readiness via periodic audits and inspections of production areas.
- Author and support deviation investigations; implement change control proposals.
- Collaborate with cross-functional QC teams (laboratory technicians, chemists, analysts) to ensure quality standards.
- Investigate customer complaints and review critical quality documents, including validation and PQR.
- Strengthen site Quality Systems by writing/revising SOPs, delivering site training, conducting internal audits, verifying inspection readiness, monitoring quality metrics, and representing the site in corporate knowledge-sharing forums.
Minimum Qualifications:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or related scientific field.
- 2+ years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment.
- Proficiency in cGMP regulations and experience with quality documentation systems.
Preferred Qualifications:
- Experience coaching or providing technical feedback to QC staff.
- Ability to handle non-standard requests and participate in regulatory audits.
- Strong technical writing skills for validation and PQR documents.
- Experience with change control implementation and deviation management.
- Ability to work effectively in cross-functional teams.
Location: Clinton, IN – Onsite Manufacturing Facility
Benefits and Perks:
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus; up to 6% 401K matching.