Entry-Level QA Specialist — GMP/Cleanroom Onsite

ProKidney Corp.; Winston-Salem (NC); On-site; USD 38,000 - 58,000; Full time

Job summary

ProKidney Corp. seeks an entry-level Quality Assurance Specialist I Contractor to support QA operations in classified manufacturing environments. The role requires full gowning and on-floor presence, with close supervision and adherence to cGMP and SOPs.

The position is onsite in Winston-Salem, NC, Monday–Friday 10am–6:30pm with overtime as needed. Prior GMP exposure or related lab experience is preferred but not required; strong documentation discipline is essential.

Qualifications

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

Responsibilities

• Support senior QA personnel during real-time manufacturing and facility activities in classified environments.
• Maintain continuous on-floor presence to support compliance and production activities.
• Assist with basic in-process 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.

Skills

GMP concepts understanding

Attention to detail

Documentation accuracy

Organizational skills

Communication & collaboration

Gowning / cleanroom compliance

Education

Bachelor’s degree in Biotechnology, Biology, Chemistry, or related field

Equivalент combination of education and experience

Job description

ProKidney Corp. seeks an entry-level Quality Assurance Specialist I Contractor to support QA operations in classified manufacturing environments. The role requires full gowning and on-floor presence, with close supervision and adherence to cGMP and SOPs.

The position is onsite in Winston-Salem, NC, Monday–Friday 10am–6:30pm with overtime as needed. Prior GMP exposure or related lab experience is preferred but not required; strong documentation discipline is essential.