Quality Assurance Engineer: 26-03049

Akraya, Inc.; Greenville (NC); Presencial; USD 69 000 - 74 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

cGMP Compliance

Aseptic Technique

Deviation Investigation

Process Improvement

Technical Writing

Descrição da oferta de emprego

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 PM - 6 AM (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.

ABOUT AKRAYA

Akraya is an award‑winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment.

Most recently, we were recognized Stevie Employer of the Year 2025, SIA Best Staffing Firm to work for 2025, Inc 5000 Best Workspaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022)!

Industry Leaders in Tech Staffing As Talent solutions provider for Fortune 100 Organizations, Akraya's industry recognitions solidify our leadership position in the IT staffing space.