Senior QC Compliance Specialist
$80,000–$100,000 year
On-siteFishers, Indiana, United States
Job Summary
Conduct in-depth technical data review of all analytical and microbiological testing for finished products, in-process samples, stability samples, raw materials, and environmental samples to ensure GMP compliance and data integrity. Generate QC data summary documents, certificates of analysis, and stability study reports while performing laboratory investigations, deviations, and change controls to determine root causes and propose CAPAs. Provide SME support for electronic QC database systems, draft specifications, protocols, and SOPs, and mentor analysts on GMP fundamentals and analytical testing. Partner with clients for onboarding, production, and stability support, manage the Site Stability Program, and assist with instrument troubleshooting and calibrations. Handle hazardous waste with mandatory annual training. Based in Fishers, IN, this full-time role requires a Bachelor's degree in Chemistry, Biology, or related sciences with 8+ years of lab or quality experience.
Required Qualifications
- Bachelor's degree in Chemistry, Biology, or related sciences
- Analytical and/or microbiology experience
- 8+ years of experience in lab or quality roles
- Must be authorized to work in the United States on a full-time basis
Desired Qualifications
- Advanced degree
- Experience in QC testing
- Experience with data review
- Experience in regulated industries
- Experience with technical writing and root cause analysis
- Experience in client relations
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.