Onsite QA Specialist II in GMP Cleanrooms

ProKidney; White Settlement (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

ProKidney Corp. is seeking a QA Specialist II to support real-time quality assurance in classified manufacturing environments. The role requires full on-site presence, gowning in cleanrooms, and collaboration with Manufacturing, Quality Control, and Facilities.

The position emphasizes adherence to cGMP, accurate documentation, and active participation in audits and investigations. Some overtime may be required to meet manufacturing needs.

Qualifications

• Bachelor's degree or equivalent in biosciences or related field.
• Minimum 2 years of QA experience in GMP manufacturing, lab, or quality setting.
• Exposure to aseptic manufacturing preferred.
• Strong knowledge of cGMP principles and quality systems.

Responsibilities

• Provide real-time QA support for low-complexity manufacturing and facility activities.
• Maintain continuous on-floor presence to support compliance and production.
• Review in-process batch records for accuracy and compliance.
• Review logs, equipment use records, and cleaning logs; follow up on discrepancies.
• Conduct line clearance activities using established procedures.
• Identify and document quality observations; escalate higher risk issues as needed.
• Support deviation documentation, investigations, and remediation with guidance.
• Participate in audits, inspections, and cross-functional quality initiatives.

Skills

cGMP knowledge

Documentation accuracy

On-floor presence

Organizational skills

Communication

Collaboration

Gowning in cleanroom

Education

Bachelor's degree in Biotechnology/Biology/Chemistry

Job description

ProKidney Corp. is seeking a QA Specialist II to support real-time quality assurance in classified manufacturing environments. The role requires full on-site presence, gowning in cleanrooms, and collaboration with Manufacturing, Quality Control, and Facilities.

The position emphasizes adherence to cGMP, accurate documentation, and active participation in audits and investigations. Some overtime may be required to meet manufacturing needs.