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 Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.
Catalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing group. A QA Associate I must be familiar with applicable GMPs. This individual will be responsible for evaluating the compliance of documents such as batch records, equipment records, environmental monitoring records, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills.

• Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP (Good Manufacturing Practices) regulations
• Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents
• Liaison between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status
• Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections
• Reviews and approves GMP product labels
• Support GMP manufacturing activities including release of GMP materials, shipment verification and performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs
• Other duties as assigned