Catalent, Inc. is looking to solve issues related to quality systems execution, client audits, regulatory inspections, and the coordination and tracking of audit observations and commitments to ensure timely and complete resolution.
Requirements
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820
- SME/Expert in all Microsoft Applications i.e. EXCEL, PowerPoint, Access, Teams and Sharepoint
- Expert knowledge of biological regulations (21 CFR Part 600s) or EU GPs, a plus
- Proficient with electronic systems, including developing and producing reports.
Responsibilities
- Responsible for and administers Audit systems for tracking statuses, follow-up, and liaison with applicable department owners to ensure their complete and timely response and resolution for observations and subsequent commitments.
- Perform trending review of observations and commitments, compile report and identify trends or areas requiring additional actions
- Host client audits and regulatory inspections
- Manages site audit schedule(s)
- Tracks Audit Commitment findings to closure
- Create and deliver Quality System/Compliance training as required
- Compile pertinent metrics for Senior Leadership review
Other
- Masters’ degree in a Scientific, Engineering or Biotech field with 6 – 8 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
- ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
