Description:
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:
- Facilitate the implementation, administration, and maintenance of documentation systems including EDMS, TrackWise, and FileTrail
- Management of department processes including controlled document revision, document issuance, document retirement, on- and off-site record archival, record destruction, and quality systems metrics
- Act as a subject matter expert (SME) for the creation/revision of SOPs, forms, and work instructions related to the above processes within the Catalent EDMS
- Support and/or ownership of investigation of deviations related to department systems
- Leadership of site Document Control, Records Center, and Systems Administration departments and personnel
- Support other activities within the Quality Systems department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, and other quality or regulatory activities, as needed
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
- All other duties as assigned
The Candidate:
- Bachelor’s degree is required
- At least three years of Quality Assurance experience under Good Manufacturing Practices (GMP) regulatory requirements is preferred
- Experience with document control and/or record archiving systems is preferred
- Possesses problem-solving and decision-making skills to identify and solve work-related issues
- Supervisory/Management experience is preferred
- Experience with Microsoft Word, Excel and PowerPoint is preferred
- Experience with TrackWise, SharePoint and other relevant software systems is preferred
- Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds