QA Engineer

• Review and/or approve basic and technical documentation including SOPs, batch production records, commissioning/qualification/validation protocols and reports, deviation reports, CAPA plans, technical and QC data, drug substance/product reports and QA trending data
• Draft and review internal Quality policies, procedures and reports
• Perform inspection of final product containers and review/approve executed process records and data
• Perform Quality audit functions (lab notebooks, equipment logbooks, vendor/supplier/contract laboratory audit questionnaires)
• Lead vendor, supplier, contract laboratory and client audits
• Identify process and Quality System improvement opportunities
• Provide daily guidance for QA department compliance to national and international standards and regulations
• Support Regulatory, client, and internal audits and act as QA liaison to internal departments and external client/vendor quality groups
• Promptly notify Senior Management of potential quality or regulatory issues
• Assist with technical oversight/training for the QA team and compliance related functions
• Ensure priority task coverage, escalate issues to Quality Management as needed
• Perform other duties as assigned

Senior QA Analyst, Analytical

Senior QA Specialist, IMSC, NC, CAPA

Senior QA Specialist – IMSC, NC, CAPA

Quality Assurance – Data Analytics

Clinical Quality Assurance Auditor

Lead