Quality Assurance Associate I, Manufacturing

Quality Assurance (QA) Associate I, Manufacturing 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. 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. 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 is a full-time hourly position on 1st shift Monday-Friday. 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: 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 The Candidate: High school diploma/GED is required, Bachelor’s degree desirable Experience is preferred in GXP manufacturing environment or similar Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude Physical requirements:

must be able to lift up to 50lbs and walk, stand, or sit for extended periods of time Catalent offers a competitive salary with bonus potential and a range of benefits, including 152 hours of PTO, 10 paid holidays, and a generous 401K match. Catalent is an Equal Opportunity Employer, including disability and veterans.

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