Quality Assurance Engineer: 26-03049

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

Pay Range

$50/hr - $54/hr

Shift

6 AM - 6 PM (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.

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