QA Specialist 2, Floor Support

NCBiotech; Winston-Salem (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

ProKidney in North Carolina is seeking a Quality Assurance Specialist II to support real-time operations in classified GMP manufacturing environments. The role requires full gowning, on-floor presence, and strict documentation accuracy, with routine batch record reviews and deviation support under supervision.

This onsite position offers a day shift Sunday–Thursday 7am–3:30pm with overtime as needed. Candidates should hold a Bachelor's in biotech/biology/chemistry and have at least two years of

Qualifications

• Bachelor's degree or equivalent in biotech/chemistry-related field.
• At least 2 years of QA experience in GMP manufacturing or related setting.
• Exposure to aseptic environments is a plus.

Responsibilities

• Provide real-time QA support for routine manufacturing and facility activities in classified environments.
• Maintain continuous on-floor presence to ensure compliance and production support.
• Perform basic in-process batch record reviews and logbook reviews for accuracy.

Skills

cGMP principles

Documentation accuracy

On-floor presence

QA in manufacturing

Education

Bachelor's degree in Biotechnology/Biology/Chemistry

Job description

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. The shift is Sunday - Thursday 7am-330pm with overtime and flexibility 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; escape 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

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.