Catalent, Inc. is looking to hire a Quality Assurance (QA) Associate I to ensure the compliance of manufacturing processes and documentation with applicable GMPs, thereby supporting the development, manufacturing, and supply of products that help people live better and healthier lives.
Requirements
- Must be familiar with applicable GMPs.
- Experience is preferred in GXP manufacturing environment or similar
Responsibilities
- 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
- This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills.
- This is a full-time hourly position on 1st shift Monday-Friday.
- Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude
- must be able to lift up to 50lbs and walk, stand, or sit for extended periods of time
- High school diploma/GED is required, Bachelor’s degree desirable
