Quality Assurance Associate

Quality Assurance Associate

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 Assurance Associate is responsible for the quality support functions associated with the manufacturing of solid dosage products for a given business unit. The Quality Assurance Associate is responsible for the oversight of manufacturing operations through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

Shift: 1st (Monday-Friday 6 AM- 2:30 PM). This position is 100% on-site in Winchester, Kentucky.

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

• Recommend SOP and batch record changes as needed

• Review proposed SOP revisions and provide feedback to management

• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters

• Perform room and equipment clearances per procedure following cleaning conducted by production; Perform microbial swabbing of equipment and room surfaces for environmental monitoring.

• Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.

• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.

• Assist in investigations for deviations by supporting data gathering and root cause analysis

• Support site process improvements (training, efficiency projects, implementation of CAPAs); Supports customer complaint investigation by performing inspection of retains and complaint samples.

• Other duties as assigned.

The Candidate

• Bachelors Degree in related science or technical field preferred with 2+ years of prior work experience; OR HS Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.

• Lean Six Sigma, ASQ Certification, or other professional certification preferred.

• Familiarity with basic laboratory instrumentation.

• 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

• Several Employee Resource Groups focusing on D&I 

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• Generous 401K match

• 152 hours accrued PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials