Senior QA Associate — Quality Assurance & Compliance (GMP)

Elanco in; Clinton (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns

8-week parental leave

Employee Resource Groups

Annual bonus offering

401K matching

Job summary

Elanco is seeking a Senior Associate – Quality Assurance for an onsite role at the Clinton, IN manufacturing facility. You will provide quality control support, assist in laboratory investigations, PQRs, and method validation activities while maintaining GMP compliance and inspection readiness.

Collaborating across QC teams, you will investigate customer complaints and review critical quality documents including validation and PQR, and help strengthen site Quality Systems through SOPs, training,

Qualifications

• Proficiency in cGMP regulations.
• Experience with quality documentation systems.

Responsibilities

• Provide quality control support by assisting in investigations, PQRs, and method validation activities.
• Maintain GMP compliance and inspection readiness for regulatory agencies through periodic audits and inspections of production areas.
• Facilitate continuous improvement by authoring and supporting deviation investigations and implementing change control proposals.
• Collaborate effectively across cross-functional QC teams, including laboratory technicians, chemists, and analysts, to ensure quality standards.
• Investigate customer complaints and review critical quality documents, including validation and PQR.
• Support and strengthen site Quality Systems by writing and revising SOPs, delivering site training, conducting internal audits, verifying inspection readiness, monitoring quality metrics, and representing the site in corporate knowledge-sharing forums.

Skills

cGMP regulations

Quality documentation systems

Education

Bachelor's degree in Chemistry, Biology, Pharmacy, or related field

Job description

Elanco is seeking a Senior Associate – Quality Assurance for an onsite role at the Clinton, IN manufacturing facility. You will provide quality control support, assist in laboratory investigations, PQRs, and method validation activities while maintaining GMP compliance and inspection readiness.

Collaborating across QC teams, you will investigate customer complaints and review critical quality documents including validation and PQR, and help strengthen site Quality Systems through SOPs, training,