Quality Management System Specialist
Core
Maintain quality management systems to ensure compliance with Good Manufacturing Practices in a pharmaceutical manufacturing startup environment.
Role type
Quality Management System Specialist
Builds
Pharmaceutical manufacturing site operations and regulatory compliance
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Quality Management Systems, Good Manufacturing Practices (GMP), supplier assessment, internal audit, corrective action, document control, regulatory compliance, change control, deviation investigation
Preferred skills
FDA/HPFBI inspection experience, controlled document generation, quality management software proficiency, project team leadership
Technologies
Microsoft Office Suite, quality management systems software
Responsibilities
Participate in quality system areas including customer regulatory inquiries, change control, and document control; maintain supplier assessment program; lead internal audit schedule and support regulatory audits; support preparation of quality systems trend reports; participate in investigations and corrective action for deviations; conduct compliance reviews of site procedures; develop Quality Management System for optimal efficiency.
Seniority
Mid-level, hands-on IC