Quality Assurance Engineer: 26-03048

Akraya, Inc.; Greenville (NC); On-site; USD 69,000 - 74,000; Full time

Job summary

Akraya, Inc. in Greenville, NC is seeking a Quality Specialist for sterile manufacturing to uphold GMP standards and ensure regulatory compliance for commercial products and development services.

You will lead investigations of deviations, guide aseptic techniques on the production floor, and drive continuous process improvements and a strong quality culture. This 9-month, onsite role offers a competitive pay rate of $50–$54 per hour and requires extensive cGMP knowledge and pharmaceutical

Qualifications

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

Responsibilities

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

Skills

cGMP Compliance

Aseptic Technique

Deviation Investigation

Process Improvement

Technical Writing

Job description

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

Contract Type: W2

Duration: 9 Months

Location: Greenville, NC (#LI - Onsite)

Pay Range: $50/hr - $54/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.