Sterile QA Engineer (Night Shift) - cGMP & Deviation Expert

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

Job summary

Akraya is seeking a Quality Specialist for sterile manufacturing in Greenville, NC to uphold quality standards and ensure regulatory compliance for commercial products and development services. The role focuses on enhancing operational efficiency through practical process improvements and a strong quality culture, providing expert guidance and hands-on support on the production floor.

The position requires significant pharmaceutical industry experience, with a preference for aseptic or sterile

Qualifications

• Extensive knowledge of cGMP regulations.
• Proven experience in pharmaceutical sterile manufacturing.
• Ability to analyze and troubleshoot production issues.
• Experience in pharmaceutical industry with 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 Compliance

Aseptic Technique

Deviation Investigation

Process Improvement

Technical Writing

Job description

Akraya is seeking a Quality Specialist for sterile manufacturing in Greenville, NC to uphold quality standards and ensure regulatory compliance for commercial products and development services. The role focuses on enhancing operational efficiency through practical process improvements and a strong quality culture, providing expert guidance and hands-on support on the production floor.

The position requires significant pharmaceutical industry experience, with a preference for aseptic or sterile