Quality Engineer III - Sterile Pharma | Night Shift

Akraya, Inc.; Greenville (NC); In loco; USD 72.000 - 77.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

cGMP regulations

Sterile pharmaceutical manufacturing

Troubleshooting production issues

Aseptic/sterile processing

Descrizione del lavoro

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.