Quality Assurance Specialist 3, Floor Support at PROKIDNEY – Winston-Salem, North Carolina

Position Summary

The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations.

This role is an onsite position in Winston Salem, NC 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.

Essential Duties & Responsibilities

• Provide QA review of moderatecomplexity manufacturing operations in classified environments.
• Maintain continuous onfloor presence to support compliance, production activities, and issue resolution.
• Conduct complex inprocess batch record reviews and evaluate documentation for compliance and accuracy.
• Review manufacturing records, environmental monitoring data, and related documentation.
• Perform and verify line clearance activities for assigned processes.
• Identify, document, and resolve standard quality issues; escalate higher-risk or non-routine issues as required.
• Support and contribute to deviation investigations, CAPAS, and remediation activities.
• Review and approve facility alarms, work orders, and returntoservice documentation.
• Participate in internal audits, inspections, and crossfunctional quality initiatives.
• Follow all gowning, safety, and cleanroom behavior requirements.

Education & Experience Requirements

• Bachelors degree in an applied science field or equivalent experience.
• 5 years of QA experience in a GMPregulated manufacturing or quality environment
• Aseptic manufacturing experience preferred.

Knowledge & Skills

• Solid professional knowledge of cGMP regulations and quality systems.
• Ability to apply judgement to moderately complex quality issues.
• Strong documentation, analytical and problem-solving skills.
• Effective cross-functional communication and collaboration.
• Ability to manage multiple priorities with limited supervision.

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.
• Ability to stand for extended periods and perform physical tasks as required.