New · posted Oct 15
Prokidney · Biotechnology
Quality Assurance Specialist 3, Floor Support
- Winston-Salem, NC
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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 requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work.
What you need
Education & Experience Requirements
- Bachelor’s degree in an applied science field or equivalent experience.
- 5 years of QA experience in a GMP‑regulated 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.
What you'll do
- Provide QA review of moderate‑complexity manufacturing operations in classified environments.
- Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.
- Conduct complex in‑process 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 return‑to‑service documentation.
- Participate in internal audits, inspections, and cross‑functional quality initiatives.
- Follow all gowning, safety, and cleanroom behavior requirements.
Where you'll work
Winston-Salem, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Winston-Salem, NCWorking conditions
- This position requires full‑time 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.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
Equal opportunity, accessibility and legal noticesProkidney's statements, word for word
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in North Carolina7 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| North Carolina (middle half) | $99,500 | $122,000 | $132,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Prokidney's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance6
- Documentation and SOPs6
- Collaboration and leadership2
- Lab testing and methods1
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Prokidney on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality6 100%
By level
- Director4 67%
- Manager1 17%
- Senior & Principal1 17%
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Quality Assurance Specialist 3, Floor Support at Prokidney
Open until filled.