Compliance Specialist
Core
Assisting with internal audit systems to ensure production and support functions at a manufacturing facility operate in compliance with applicable regulations and standards.
Role type
Compliance Specialist
Builds
Internal audit systems and compliance assurance for manufacturing operations
Domain
Biopharmaceutical manufacturing
Deliverable
client delivery
Required skills
Internal audit planning and execution, Regulatory agency inspection support, Action plan development and tracking, Supplier qualification management, Metrics collection and analysis for CAPA, GMP compliance evaluation, Problem investigation and resolution
Preferred skills
Quality Assurance, Regulatory Affairs, Pharmaceutical regulations knowledge (CFR, MCA, DEA), Plant and company procedure knowledge
Technologies
None stated
Responsibilities
Assists with planning and conducting internal compliance audits of all operations within the facility, Provides support with company and regulatory agency (i.e. DEA, FDA) inspections, Follow up on audits to assure that action plans are developed and completed in a timely fashion, Assist with management review and associated metrics for the plant, Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's), Responsible for supplier qualifications including new suppliers, changes and re-qualifications
Seniority
Mid-level, hands-on IC