Senior QA Specialist — GMP & Quality Improvement

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

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns (mid-summer and

year-end) in the US (in addition to PT

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco in Clinton, IN, is seeking a Senior Associate for Quality Assurance to support GMP-compliant lab investigations, method validation, and continuous improvement initiatives. You will work in the Clinton Quality Control Unit providing essential quality systems support.

You will collaborate with QC teams, write and revise SOPs, assist in audits, review PQRs, and help ensure inspection readiness while advancing product quality and customer satisfaction.

Qualifications

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

Responsibilities

• Provide quality control support by assisting in laboratory investigations, PQRs, and method validation.
• Maintain GMP compliance and inspection readiness through audits and inspections of production areas.
• Facilitate continuous improvement by authoring deviation investigations and supporting change control proposals.
• Collaborate with 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 SOPs, delivering site training, conducting internal audits, and monitoring quality metrics.

Skills

cGMP regulations

Quality documentation systems

Education

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

Job description

Elanco in Clinton, IN, is seeking a Senior Associate for Quality Assurance to support GMP-compliant lab investigations, method validation, and continuous improvement initiatives. You will work in the Clinton Quality Control Unit providing essential quality systems support.

You will collaborate with QC teams, write and revise SOPs, assist in audits, review PQRs, and help ensure inspection readiness while advancing product quality and customer satisfaction.