Quality Assurance Specialist : 26-03046

Akraya, Inc.; Greenville (NC); On-site; USD 72,000 - 77,000; Full time

Job summary

Akraya, Inc. is seeking a Quality Assurance/Quality Control professional for a 10-month, W2 contract in Greenville, NC.

The role focuses on driving quality execution across sterile operations, including manufacturing, filling, packing, and inspection, with emphasis on process improvements. The position requires a Bachelor's degree in technology/engineering/microbiology, 4+ years in QA/QC/manufacturing, strong data analysis and troubleshooting skills, and solid technical writing abilities.

Qualifications

• 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).

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

Skills

Bachelor's degree

Quality Assurance

Quality Control

Manufacturing

Data analysis

Troubleshooting

Ownership

Leadership

Technical writing

Physical stamina

Education

Bachelor's degree in technology/engineering/microbiology

Job description

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