Compliance Specialist
On-siteBedford, New Hampshire, United States
Job Summary
Manage change controls, deviations, and CAPA plans within sterile fill finish operations by initiating documentation, conducting impact assessments, and leading root cause investigations. Collaborate with Quality Assurance, Manufacturing, and other departments to drive continuous improvement, maintain regulatory compliance, and ensure timely closure of all corrective actions. Act as a liaison to facilitate cross-functional communication and provide regular status updates to stakeholders. Requires 2+ years of GMP experience, a Bachelor's degree in Science or Engineering, and strong technical writing skills. Located in Bedford, New Hampshire.
Required Qualifications
- 2+ years' experience with GMP, ISO, and/or an FDA-regulated environment
- Strong technical writer and SME in writing all Quality system documents (CAPAs, Deviations, Change Controls, SOPs, Reports, etc.)
- SME in investigation, root cause, and risk analysis in a cGMP environment for complex issues within the production environment
- Strong understanding of regulatory requirements, and industry best practices
Desired Qualifications
- Bachelor's Degree in a Science or Engineering related field
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