Onsite QA Specialist II - Real-Time GMP & Cleanroom

ProKidney Corp.; Winston-Salem (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC seeks a Quality Assurance Specialist II to support routine QA in classified manufacturing environments, with full gowning and on-floor presence to ensure cGMP compliance and documentation accuracy.

This onsite, full-time role requires collaboration with Manufacturing, QC, and Facilities. Ideal candidates hold a bachelor's degree in biotech/biology/chemistry, at least 2 years of GMP QA experience, and exposure to aseptic manufacturing.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry, or related field.
• 2 years of QA experience in a GMP-regulated manufacturing, laboratory, or quality environment.
• Exposure to aseptic manufacturing preferred.

Responsibilities

• Provide real-time QA support for low-complexity manufacturing and facility activities in classified environments.
• Maintain continuous on-floor presence to support compliance and production activities.
• Perform basic in-process batch record reviews to ensure accuracy and compliance.
• Review routine documentation such as logs and cleaning records and follow up on discrepancies.
• Conduct and verify routine line clearance activities using established procedures and checklists.
• Identify and document quality observations; escalate as needed.
• Support deviation documentation, investigations, and remediation with guidance.
• Participate in audits, inspections, and cross-functional quality initiatives as assigned.

Skills

cGMP knowledge

Documentation accuracy

Attention to detail

Cross-functional communication

On-floor presence

Education

Bachelor's degree in Biotechnology/Biology/Chemistry or related field

Job description

ProKidney Corp. in Winston-Salem, NC seeks a Quality Assurance Specialist II to support routine QA in classified manufacturing environments, with full gowning and on-floor presence to ensure cGMP compliance and documentation accuracy.

This onsite, full-time role requires collaboration with Manufacturing, QC, and Facilities. Ideal candidates hold a bachelor's degree in biotech/biology/chemistry, at least 2 years of GMP QA experience, and exposure to aseptic manufacturing.