Senior Quality Assurance Specialist

Key Responsibilities

• Review and approve quality documentation, including batch records, deviations, change controls, and validation-related documents
• Partner with Manufacturing and Operations to support and/or lead deviation investigations, including root cause analysis and corrective actions
• Maintain a strong QA presence on the manufacturing floor to ensure compliance and provide real-time support
• Balance production timelines with quality requirements to support efficient operations
• Perform material review and release activities for raw materials, components, and consumables
• Support batch record review, product disposition, and overall release processes
• Mentor and provide guidance to QA team members on shift
• Make real-time quality decisions regarding deviations, product impact, and escalation needs
• Contribute to deviation investigations, CAPA development, and risk assessments
• Ensure adherence to SOPs, regulatory requirements, and site quality standards
• Utilize electronic and paper-based systems (QMS, LIMS, etc.) to maintain data integrity
• Analyze quality trends and identify sources of variability using data and statistical tools
• Manage multiple priorities in a fast-paced GMP environment

Qualifications

• Bachelor’s degree in a scientific discipline (or equivalent experience)
• 8+ years of experience in a GMP-regulated manufacturing environment
• 4+ years of direct QA oversight supporting manufacturing operations
• Experience with quality systems, including deviations, CAPA, and change control
• Strong understanding of GMP regulations and product disposition processes
• Excellent written and verbal communication skills
• Experience with data analysis tools and manufacturing systems is preferred