Catalent, Inc. is looking for a Quality Assurance Specialist to support internal non-commercial clients, external clients, and/or commercial processes and projects by performing routine and non-routine Quality Assurance tasks with minimal supervision, advocating for the improvement of quality standards and the development and maintenance of a quality culture.
Requirements
- At least 1 year of batch record review and on the floor quality assurance manufacturing support.
Responsibilities
- Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).
- Provide assistance to laboratories with appropriate quality oversight.
- Escalate unplanned events and issues, providing immediate notification to QA Management, supporting and providing guidance to laboratory staff as assigned.
- Review Quality documentation including but not limited to review of laboratory reports, CoAs, methods, specifications, method validation protocols and method validation reports.
- Remain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issues.
- Act as QA representative on project teams, providing Quality guidance and support.
Other
- Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility.
- Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards.
- Bachelor’s degree with 4 years of professional experience in the pharmaceutical industry, preferably with 2 years in a Quality role or; Associate degree with 5 years of professional experience in the pharmaceutical industry, preferably with 3 years in a Quality role.
- Position requires the capacity to handle and manipulate objects using hands and arms
- All other duties as assigned.
