Quality Assurance Auditor - Manufacturing
Catalent
Summary
This Quality Assurance Auditor – Manufacturing role requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.
Job description
Position Summary
This Quality Assurance Auditor – Manufacturing role requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.
The Role
- Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
- Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization
- 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
- Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
- Perform in-process QA checks
- Assure release of raw materials and components prior to manufacturing/packaging
- Provide real-time support activities for manufacturing and packaging operations
- Review batch records
- Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs
- Other duties as assigned
Minimum Requirements
- Bachelor’s degree with three years of experience in the pharmaceutical industry with at least one year in a direct Quality Assurance role; OR
- Associate degree with four years of experience in the pharmaceutical industry with at least two years in a direct Quality Assurance role; OR
- At least one year of batch record review and on the floor quality assurance manufacturing support
Requirements
- Bachelor’s degree with three years of experience in the pharmaceutical industry with at least one year in a direct Quality Assurance role; OR
- Associate degree with four years of experience in the pharmaceutical industry with at least two years in a direct Quality Assurance role; OR
- At least one year of batch record review and on the floor quality assurance manufacturing support
- Strong understanding of cGMP
- Ability to maintain quality standards in a manufacturing environment
Benefits
- Paid Time Off
- 8 Paid Holidays
- Medical, Dental & Vision
- Tuition Reimbursement
- Employee Resource Groups
- Wellness Program
- Onsite Fitness Center
- Perkspot Discounts
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.