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Quality Assurance Specialist

Job in Raleigh, Wake County, North Carolina, 27601, USA

Listing for: Accentuate Staffing

Full Time position
Listed on 2026-03-12

Job specializations:

Quality Assurance - QA/QC
Data Analyst

Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR

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

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