Quality Engineer III: 26-03047

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

Job summary

Akraya, Inc. is seeking a quality specialist to uphold sterility and GMP standards on the production floor in Greenville, NC. You will monitor facilities, personnel, and documentation to ensure regulatory compliance for commercial and development activities.

You will lead deviation investigations, guide staff on aseptic techniques, review complex quality documents, and drive continuous process improvements in a high‑volume sterile manufacturing environment.

Qualifications

• Extensive knowledge of cGMP regulations.
• Proven experience in pharmaceutical sterile manufacturing.
• Ability to analyze and troubleshoot production issues.
• Significant experience in pharmaceutical industry, aseptic/sterile environments preferred.

Responsibilities

• Conduct daily quality assessments of facilities, personnel, and documentation.
• Provide guidance and support to staff on aseptic techniques and GMP principles.
• Participate in and lead investigations for deviation events.
• Review and approve complex quality documentation, including procedures and change controls.
• Identify and implement opportunities for continuous process improvement.

Skills

cGMP regulations

Sterile pharmaceutical manufacturing

Troubleshooting production issues

Aseptic/sterile processing

Job description

Primary Skills

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

Contract Information

Contract Type: W2 Duration: 9 Months Location: Greenville, NC (Onsite) Pay Range: $51.50/hr - $56.50/hr Shift: 6 PM - 6 AM (2-2-3 rotation)

Job Summary

This role is crucial for upholding quality standards within sterile manufacturing environments, ensuring adherence to regulatory requirements for both commercial products and development services. The specialist will actively contribute to enhancing operational efficiency through practical process improvements and a strong quality culture. The position requires a dedicated individual who can provide expert guidance and hands‑on support on the production floor.

Key Responsibilities

• Conduct daily quality assessments of facilities, personnel, and documentation.
• Provide guidance and support to staff on aseptic techniques and GMP principles.
• Participate in and lead investigations for deviation events.
• Review and approve complex quality documentation, including procedures and change controls.
• Identify and implement opportunities for continuous process improvement.

Must‑Have Skills

• Extensive knowledge of cGMP regulations.
• Proven experience in pharmaceutical sterile manufacturing.
• Ability to analyze and troubleshoot production issues.
• This role requires significant experience within the pharmaceutical industry, with a strong preference for aseptic or sterile processing environments.