Sterile QA Engineer III - Onsite cGMP Process Improvement

Akraya; Greenville (NC); Presencial; USD 71.000 - 78.000; Jornada completa

Descripción de la vacante

Akraya is seeking a Quality Assurance professional to ensure quality standards in sterile manufacturing operations in Greenville, NC. The role involves monitoring production processes, guiding on quality matters, and supporting product development.

You will actively participate in deviations investigations, review documents, and contribute to continuous improvement initiatives. A hands-on approach to maintaining compliance is required for this 9-month W2 on-site assignment.

Formación

• Experience in sterile pharmaceutical manufacturing and cGMP environments.
• Ability to analyze process issues and implement corrective actions.
• Familiarity with documentation control and change management.

Responsabilidades

• Monitor sterile manufacturing processes for adherence to procedures.
• Assist personnel with quality-related issues and documentation.
• Participate in investigations of deviations and implement corrective actions.
• Review and approve controlled documents such as procedures and training materials.
• Identify and support opportunities for process optimization.

Conocimientos

cGMP compliance

Deviation investigation

Process improvement

Technical writing

Aseptic technique

Descripción del empleo

Akraya is seeking a Quality Assurance professional to ensure quality standards in sterile manufacturing operations in Greenville, NC. The role involves monitoring production processes, guiding on quality matters, and supporting product development.

You will actively participate in deviations investigations, review documents, and contribute to continuous improvement initiatives. A hands-on approach to maintaining compliance is required for this 9-month W2 on-site assignment.