Quality Assurance Specialist

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing company who is hiring a Quality Assurance Specialist to join their QA Compliance team. This role will support deviation investigations, root cause analysis, CAPA development, and OOS investigations within a cGMP-regulated manufacturing environment. This is a great opportunity for someone who enjoys digging into quality events, identifying root cause, and driving corrective actions that improve overall site compliance and performance.

• Investigate minor, major, and critical deviations, ensuring timely and compliant completion of investigations
• Perform root cause analysis and recommend CAPAs to prevent recurrence of quality issues
• Conduct Phase II OOS investigations and support quality event documentation
• Support regulatory and customer audits, including documentation review and audit readiness activities
• Assist with quality metrics trending, APR data compilation, and KPI reporting
• Participate in continuous improvement initiatives and Kaizen activities
• Track investigation progress and report updates to management

• Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or related science field preferred
• 3+ years of experience in pharmaceutical, biotech, or other FDA-regulated manufacturing environments
• Experience with deviations, investigations, CAPA, OOS, and GMP quality systems
• Strong documentation practices and experience writing investigation reports
• Proficiency with MS Office and experience with systems such as SAP or electronic quality management systems is a plus
• Strong attention to detail and ability to collaborate cross-functionally