- Location
- Winston-Salem, North Carolina, United States
- Workplace
- Remote, Hybrid, Onsite
- Department
- Quality Management
- Visa
- Not sponsored
- Source
- Greenhouse
Description
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.
Essential Duties & Responsibilities
- 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.
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.
Working 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.
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.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
