Quality Assurance Specialist
Accentuate Staffing
Raleigh, NC
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
About the Company
Accentuate Staffing
Since 1996, Accentuate Staffing has delivered “The Power of Positive” to you. As one of the Triangle’s largest woman-owned companies, Accentuate Staffing sources candidates in the career specialties of Accounting/Finance, Office Professional, Information Technology, Scientific/Clinical, Light Industrial and R&D Consulting services. The current roster of more than 250 corporate clients is diverse, highly regarded, and often exclusive. Accentuate Staffing’s honors include nine Triangle Business Journal Fast 50 awards, four Raleigh Chamber Pinnacle Awards, No. 222 on the INC 500 list and an inaugural winner of the TBJ’s A Better World Award. Accentuate Staffing cherishes its position as a leader in the community, offering support to charitable institutions including Children’s Flight of Hope, National Students of AMF, the MS Society, the Shepard’s Table Soup Kitchen, and Stop Hunger Now among others. For detailed information on how “The Power of Positive” can impact your company or your career, please visit at www.accentuatestaffing.com.