Quality Engineer III: 26-03367

Akraya Inc.; Greenville (NC); Vor Ort; USD 71.000 - 78.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

cGMP compliance

Deviation investigation

Process improvement

Technical writing

Aseptic technique

Jobbeschreibung

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

Job Summary

This role focuses on ensuring quality standards are met within sterile manufacturing operations. You will actively monitor production processes, provide guidance on quality matters, and contribute to continuous improvement initiatives. The position requires a hands-on approach to uphold compliance and support product development.

Key Responsibilities

• 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.

Must-Have Skills

• Understanding of cGMP regulations.
• Ability to analyze process issues.
• Effective communication and guidance skills.

Domain / Industry Experience

Previous experience in the pharmaceutical industry, particularly with aseptic or sterile processes, is highly preferred, although experience in other regulated environments like ISO 9001 may be considered.

Primary Skills

• cGMP Compliance [intermediate]
• Deviation Investigation [intermediate]
• Process Improvement [beginner]
• Technical Writing [intermediate]
• Aseptic Technique [intermediate]