Position Summary
The Quality Assurance (QA) Specialist II supports routine quality assurance operations within classified manufacturing environments, including cleanrooms. Working with moderate supervision, the Specialist II applies Good Manufacturing Practices (cGMP) to perform defined QA activities, support real-time manufacturing operations, and ensure documentation accuracy and compliance. The role involves full gowning, continuous on-floor presence, and collaboration Manufacturing, Quality Control, and Facilities to support manufacturing operations.
This role is an onsite position requiring full‑time presence in classified manufacturing environments. Flexibility and overtime may be needed based on the needs of the business. 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 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 logbooks, equipment use records, and cleaning logs and follow up on discrepancies.
- Conduct and verify routine line clearance activities using established procedures and checklists.
- Identify and document quality observations; escalate non-routine or higher risk issues as appropriate.
- Support deviation documentation, investigations, and remediation with guidance.
- Participate in audits, inspections, and cross-functional quality initiatives as assigned.
- Follow all gowning, safety, and cleanroom behavior requirements.
Education & Experience Requirements
- Bachelor’s degree in Biotechnology, Biology, Chemistry, or related field; or equivalent combination of education and experience.
- 2 years of QA experience in a GMP‑regulated manufacturing, laboratory, or quality environment.
- Exposure to aseptic manufacturing preferred.
Knowledge & Skills
- Working knowledge of cGMP principles and quality systems.
- Ability to apply defined procedures and exercise judgement within established parameters.
- Strong attention to detail and documentation accuracy.
- Effective organizational, communication, and collaboration skills.
- Ability to perform physical tasks and work in gowning-required environments.
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.
