Quality Control Auditor

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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 material/in process/finished good data for release

Shift: Monday-Friday 7 AM-4 PM

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

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 analytical testing as needed

• Assist in laboratory investigations

• Draft or review standard operating procedures as needed

• Draft or review CAPAs and audit responses as needed

• Other duties as assigned

The Candidate

• Bachelor’s Degree (Preferred in Chemistry or equivalent) Required.

• Work Experience – 3+ Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role (including internships or co-op experience).

• General computer literacy including use of Microsoft Word and Excel.

• Safely perform testing required by position. Knowledge of and proper use of equipment. Safely handling chemicals and compounds.

• Regular cleaning of lab space as required. Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.

• Maintaining clean environment for laboratory operations. Use of and safe handling of glass canisters, chemicals, and other required equipment. 

Why You Should Join Catalent