Specialist PQA

Requirements

• Provide QA support for Commissioning & Qualification (C&Q) activities, including review/approval of protocols and reports
• Actively support New Product Introduction (NPI) to ensure quality requirements are embedded from early stages through commercialization
• Lead and support Quality Systems processes, including: Deviations, Product Disposition, CAPAs, Change Controls
• Ensure timely, thorough, and compliant investigations, driving effective root cause analysis and sustainable solutions
• Support batch disposition activities in alignment with packaging operations and quality requirements
• Partner with cross-functional teams to ensure quality systems are effectively implemented during B2 startup and ramp-up
• Drive and contribute to Continuous Improvement (CI) initiatives to enhance quality system performance and efficiency
• Ensure that changes impacting product quality are appropriately assessed and implemented through Change Control processes
• Maintain inspection readiness and support internal/external audits and regulatory inspections
• Identify and escalate quality and compliance risks
• Collaborate closely with Packaging, Engineering, PD, Supply Chain, and QC to ensure seamless execution

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models