Quality Control Auditor

Job description

Quality Control Auditor Position Summary: Typical working hours for the position are Monday-Friday 8 AM-5 PM. This position is 100% on-site in Winchester, Kentucky. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Quality Control Auditor supports release of all materials from the quality control lab. The Quality Control Auditor is responsible for GMP and technical review of raw materials/in process/finished goods data for release. The Role: Support release of raw materials, in-process, finished product by reviewing GMP documents (data, notebooks, certificate of analysis, validation/qualification reports, etc) for compliance to internal SOPs and approved test methods as well as technical accuracy Read and understand test methods from multiple compendia (i.e. USP/NF, EP, JP), internal Catalent methods, or customer/supplier methods+ Participate in customer/agency audits as necessary Assist in training QC Analysts: Perform ana...