Summary:
Looking to expand your quality career with a top-tier global life sciences leader? We are seeking a detail-oriented Compliance Specialist to lead non-conformance investigations and quality resolution for production operations in Ridgefield, NJ. If you bring strong investigative instincts and cGMP experience within a reasonable commute, this is an excellent opportunity to make a direct impact on operational quality.
Responsibilities:
- Investigate, author, and manage non-conformance reports (NCRs) for production and environmental monitoring (EM) events.
- Perform root cause analysis to identify underlying issues and document comprehensive investigation findings.
- Collaborate with cross-functional teams to design, implement, and track actionable CAPAs.
- Conduct effectiveness checks (ECs) to verify CAPA outcomes and prevent recurring quality issues.
- Ensure continuous compliance with cGMP, ISO 9001, and FDA guidelines across all manufacturing activities.
Qualifications:
- 2+ years of hands-on experience authoring, investigating, and managing NCRs and deviations in a cGMP manufacturing environment.
- Working knowledge of CAPA management, effectiveness checks, and document control systems.
- Strong familiarity with regulatory standards including cGMP, ISO 9001, and FDA guidelines.
- Proven tenure and stability in previous quality assurance or manufacturing roles.
- Local to Ridgefield, NJ (within a 45-minute commute) to support potential overtime and weekend needs.