Quality Assurance Specialist 1 Contractor in Winston-Salem, North Carolina at PROKIDNEY

Winston-Salem, North Carolina, United States

Position Title: Quality Assurance Specialist 1 Contractor

Position Summary

The Quality Assurance (QA) Specialist I Contractor is an entry-level role that supports quality assurance operations within classified manufacturing environments, including cleanrooms. Working under close supervision, the Specialist learns and applies foundational Good Manufacturing Practices (cGMP) while assisting senior QA staff with routine daily activities. The role requires full gowning, continuous on-floor presence, and a strong focus on accuracy, documentation, and adherence to established procedures to support manufacturing operations.

This role is an onsite position requiring fulltime presence in classified manufacturing environments. Due to the handson, realtime nature of quality activities, this role is not eligible for remote or hybrid work. The shift is Monday - Friday 10am-630pm with over time and flexibility needed based on the needs of the business. Due to the handson, realtime nature of quality activities, this role is not eligible for remote or hybrid work.

Essential Duties & Responsibilities

• Support senior QA personnel during realtime manufacturing and facility activities in classified environments.
• Maintain continuous onfloor presence to support compliance and production activities.
• Assist with basic inprocess batch record reviews by performing completeness and accuracy checks under supervision.
• Review routine documentation such as logbooks, equipment use records, and cleaning logs for completeness and adherence to SOPs.
• Assist with routine line clearance activities following established checklists and procedures.
• Recognize and report quality observations or documentation discrepancies to senior QA staff.
• Support deviation documentation, investigations, and remediation activities under supervision.
• Participate in required GMP, safety, and compliance training programs.
• Follow all gowning, safety, and cleanroom behavior requirements.

Education & Experience Requirements

• Bachelors degree in Biotechnology, Biology, Chemistry, or related field; or equivalent combination of education and experience.
• 0-1 year of experience in a GMPregulated, manufacturing, laboratory, or quality environment
• Exposure to aseptic manufacturing preferred but not required.

Knowledge & Skills

• Foundational understanding of GMP concepts or willingness to learn.
• Strong attention to detail and commitment to documentation accuracy.
• Basic organizational, communication, and collaboration skills.
• Ability to perform physical tasks and work in gowning-required environments.

Working Conditions

• This position requires fulltime onsite work in a GMP manufacturing environment.
• Not eligible for remote or hybrid work.
• Requires full gowning and extended time in cleanroom and classified areas.