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
Responsibilities:
- 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
Requirements:
- 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
