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Job Overview
Employment Type
Full-time
Work Schedule
Standard Hours
Benefits
Defined career path
Annual performance review
Diverse inclusive culture
Career growth potential
Paid Time Off
Paid holidays
401k Match
Medical insurance
Dental Insurance
Vision Insurance
Tuition Reimbursement
Job Description
Catalent is a global leader in drug development, delivery, and supply, operating a state-of-the-art 206,878-square-foot facility in the Philadelphia area that serves as the global Center of Excellence for Clinical Supply Packaging. This facility offers GMP secondary packaging and clinical labeling services ranging from manual to fully automated packaging solutions, including temperature-controlled options for sensitive pharmaceutical products. Catalent is committed to innovation, quality, and excellence, supporting more than 7,000 life-saving and life-enhancing products globally. The organization partners directly with pharmaceutical, biopharmaceutical, and consumer health companies to advance new medicines through early development, clinical trials, and market launching. As a company... Show More
Job Requirements
- Bachelor's degree required
- Life sciences or scientific discipline preferred
- Minimum five years relevant experience in pharmaceutical or life sciences industry
- Experience with regulatory or client audits
- Strong communication and presentation skills
- Knowledge of cGMP requirements
- Ability to work Monday through Friday, 8:00 am to 4:30 pm on-site
- Strong organizational skills and flexibility
Job Qualifications
- Bachelor's degree, life sciences or scientific degree preferred
- Five years of relevant experience working in pharmaceutical or life science industry
- Regulatory and/or client audit experience
- Ability to present quality/compliance information internally and externally
- Knowledge of current good manufacturing practices (cGMP)
Job Duties
- Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests
- Plan, schedule, manage, and host customer, corporate, and internal audits
- Support regulatory inspections as required
- Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions
- Attend project kick-off meetings to assist various departments with understanding the project from a quality perspective
- Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered
- Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff
- Be knowledgeable about customer-specific requirements
- Ensure they are built into the process and communicated to relevant Catalent staff
- Review deviation and complaint reports and address trends
- Prepare communications regarding the results where appropriate and requested
- Other duties as assigned
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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