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Quality Assurance Specialist

Job in Greenville, Pitt County, North Carolina, 27834, USA
Listing for: Akraya, Inc.
Full Time position
Listed on 2026-10-08
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, Quality Engineering, Data Analyst, QA Specialist - Analyst/Manager
Salary/Wage Range or Industry Benchmark: 52 - 56 USD Hourly USD 52.00 56.00 HOUR
Job Description & How to Apply Below

Primary Skills
: cGMP Compliance (advanced), Deviation Investigation (advanced), Aseptic Technique (intermediate), Technical Writing (intermediate), Process Improvement (intermediate)

Contract Type
: W2

Duration
: 10 Months

Location
:
Greenville, NC

Pay Range
: $51.50/hr - $56.50/hr

Shift
: 6 PM - 6 AM (2-2-3 rotation)

Job Summary
:
Drive quality execution across sterile operations including manufacturing, filling, packaging, and inspection for commercial and product development services. Provide quality guidance for process improvements.

Hours
: 6p-6a, 2-2-3 rotation.

Key Responsibilities
  • Perform daily quality assessments of facility, personnel, and documentation to ensure compliance with cGMPs
  • Interact with employees on troubleshooting, documentation, and aseptic technique guidance
  • Champion quality culture and support continuous improvement initiatives
  • Participate in deviation event response and Root Cause Analysis
  • Review and approve procedures, training documents, deviations, and change controls
  • Perform quality batch record review
Must-Have Skills
  • Bachelor's degree in technology, engineering, or microbiology
  • 4+ years in Quality Assurance, Quality Control, or Manufacturing
  • Data analysis and troubleshooting expertise
  • Strong ownership and leadership abilities
  • Technical writing experience
  • Physical ability to work production floor (standing, walking, bending for prolonged periods)
Industry Experience
  • Pharmaceutical industry experience with aseptic/sterile processes strongly preferred
  • Other regulated environments (e.g., ISO 9001) considered
Professional Certifications
  • CQA and Six Sigma training a plus
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