Catalent, Inc
Principal Quality Associate, Supplier Audits
Greenville, NC · Principal
Sponsorship not specifiedDetected 1 day ago
AuditingClinical TrialsCommunicationOrganizational Skills
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About the role
- We have an opportunity for a Principal Quality Associate, Supplier Audits, to join our team.
- This role involves performing and facilitating system-based audits and risk assessments for Supplier Audits and Internal Quality Systems.
- Use TrackWise for audit management, quality events, and documentation tracking.
Responsibilities
- You will support both non-commercial and commercial audits as well as the Inspection Readiness Program.
- Manage audit schedules and coordinate audit activities with internal teams and suppliers.
- Collaborate with Site Subject Matter Experts to prepare for and support supplier audits.
- Manage TrackWise audit records and ensure timely responses to client observations and audit findings.
- Monitor site quality metrics, identify trends, and track audit observations to support continuous improvement.
- Support regulatory inspections by preparing documentation and coordinating responses to regulatory agencies.
- Maintain strong client relationships by managing supplier observations, corrective actions, and ensuring timely communication and resolution of audit findings.
- Perform supplier risk assessments and manage supplier qualification questionnaires.
Requirements
- Bachelor's degree in a technical field with at least 6 years of professional experience in the pharmaceutical industry, including 3 years in a Quality Auditing function.
- Associate degree in a technical field with at least 7 years of professional experience in the pharmaceutical industry, including 4 years in a Quality Auditing function.
- In lieu of a technical degree, at least 8 years of professional experience in the pharmaceutical industry, including 5 years in a Quality Auditing function, and completion of formal auditing training may be substituted.
- At least 5 years of experience in a direct Quality role required.
- Demonstrated knowledge of regulations and guidelines associated with current Good Manufacturing Practices for the pharmaceutical industry.
- Knowledge of manufacturing and/or laboratory processes required.
Nice to have
- Preferred Skills & Background
- ASQ Certified Quality Auditor or equivalent certification preferred.
Compensation
- Defined career path and annual performance review process with potential for career growth on an expanding team.
Benefits
- Competitive Paid Time Off plus 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement - support to finish your degree or earn a new one.
Equal opportunity
- Employee Resource Groups focusing on Diversity and Inclusion.
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