QC Compliance Specialist
INCOG BioPharma Services•Fishers, IN
•Onsite
About The Position
The Quality Control Compliance Specialist plays a vital role on the QC team with analytical and microbiological testing experience. This role will support laboratory processing of finished product, incoming materials, and stability sample release. The company culture is focused on building long-term value for customers, with a commitment to a service-culture mindset, technical excellence, and a collaborative and team-centered approach. This is a smoke-free campus.
Requirements
- Bachelor’s degree in Chemistry, Biology, or related sciences
- Analytical and/or microbiology experience
- 5+ years of experience in lab or quality roles
Nice To Haves
- Advanced degree
- Experience in QC testing
- Experience with data review
- Experience in regulated industries
Responsibilities
- Perform in-depth technical data review of all analytical and microbiological testing performed on finished products - in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs.
- Review includes both technical review of method performance as well as confirming data integrity elements, e.g. good documentation practices, audit trail reviews, etc.
- Generate QC data summary documents such as certificates of analysis and stability study summary reports.
- Provide SME support for electronic QC database systems and laboratory data integrity compliance (OpenLab etc) to support the QC laboratories.
- Revise and improve technical writing documents such as analytical methods, specifications, protocols, SOPs, templates, etc.
- Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing.
- Provide laboratory information and documentation requests to site management and customers required for regulatory filings and product import/export needs, when required.
- Provide support for instrument troubleshooting, instrument repair, and instrument calibrations for the QC laboratories.
- Handle waste including hazardous waste.
- Attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.
Benefits
- Equal Opportunity Employer
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
