Senior QA Associate - GMP & Quality Systems

Elanco; Clinton (IN); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

Shutdowns

Parental leave

Annual bonus

401K matching

Employee Resource Groups

Job summary

Elanco Tiergesundheit AG in Clinton, IN, is seeking a Senior Associate in Quality Assurance to support GMP compliance and quality systems. You will drive investigations, method validation, and continuous improvement within the Clinton QC Unit, partnering with chemists, analysts, and technicians to maintain inspection readiness.

Ideal candidates have a Bachelor’s in a scientific field and at least 2 years of QA/QC experience in a regulated manufacturing environment, with strong knowledge of cGMP

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field.
• Minimum of 2 years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment.
• Strong knowledge of cGMP regulations and quality documentation systems.

Responsibilities

• Provide QC support by assisting in laboratory investigations, PQR, and method validation activities.
• Maintain GMP compliance and inspection readiness through audits and inspections of production areas.
• Facilitate continuous improvement by authoring and supporting deviation investigations and change control proposals.
• Collaborate across cross-functional QC teams 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

Proficiency in cGMP regulations

Experience with quality documentation

Education

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

Job description

Elanco Tiergesundheit AG in Clinton, IN, is seeking a Senior Associate in Quality Assurance to support GMP compliance and quality systems. You will drive investigations, method validation, and continuous improvement within the Clinton QC Unit, partnering with chemists, analysts, and technicians to maintain inspection readiness.

Ideal candidates have a Bachelor’s in a scientific field and at least 2 years of QA/QC experience in a regulated manufacturing environment, with strong knowledge of cGMP