The Senior Compliance Auditor reports to the Quality Management Systems, Group Leader.
The Senior Compliance Auditor must be knowledgeable in pharmaceutical QA policies and practices. Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels of management. Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. Individual must be creative and able to design new systems and programs
Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.
- Assists Group Leader with customer/regulatory audits at the Catalent Somerset site to ensure compliance with cGMPs, as well as Corporate and site standard operating procedures.
- Lead the activities for preparing the site for inspections by US and foreign regulatory authorities, customers, and corporate auditors. Participate in these inspections.
- Conduct and manage the internal audit program at the site.
- Host customer audits of the facility as required. Liaise with internal and external customers as required.
- Effectively provides written responses to the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensures responses are completed as committed.
- Review and approve Trackwise PRs as needed acting as a QA Representative.
- Candidate must have a B.S. degree in Chemistry, Pharmacy or a Bachelors degree with appropriate experience with ten years of experience working in the pharmaceutical industry in Quality Assurance.
- Minimum five years of experience in compliance, auditing, QC/QA function and/or document review.
- ASQ (Certified Quality Auditor) certification is preferred, not required.
- Internal/External audit experience is a plus.
- Full understanding of FDA, cGMP and DEA regulations pertaining to clinical trial and commercial activities
- Thorough knowledge of cGMPs, ability to evaluate facilities records processes, procedures and practices for conformance to these requirements.
- Candidate must have the ability to work effectively under high pressure with multiple deadlines.
- Medical, Dental, Vision and 401K are all offered from day one of employment
- 19 days of paid time off annually + 7 paid holidays
Leadership Competencies for Performance and Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops