Manager, QA Floor Support

ProKidney; Winston-Salem (NC); On-site; USD 80,000 - 105,000; Full time

Job summary

A leading biotechnology firm located in Winston-Salem seeks a Quality Assurance On-The-Floor Manager to lead the QA team in real-time quality oversight of manufacturing activities. The role includes managing daily operations, ensuring compliance with regulatory requirements, and collaborating across departments. Candidates should possess a Bachelor’s degree and 5+ years of QA experience in cGMP environments. Strong communication, organizational skills, and a detail-oriented mindset are essential for success in this role.

Qualifications

• 5+ years relevant QA experience in cGMP aseptic manufacturing.
• Demonstrated knowledge of commercial GMP regulations for Sterile manufacturing.
• Ability to handle multiple tasks simultaneously.

Responsibilities

• Lead the QA On-The-Floor team in real-time quality oversight.
• Ensure compliance with GMP and regulatory requirements.
• Manage daily floor support operations.

Skills

Strong organizational skills

Analytical skills

Time management skills

Excellent communication skills

Attention to detail

Teamwork

Education

Bachelor’s degree in applied science or related field

Job description

Winston-Salem, North Carolina, United States

Position Summary

The Quality Assurance On-The-Floor (OTF) Manager is responsible for leading the QA On-The-Floor team and providing real-time quality oversight of clinical and commercial manufacturing activities at ProKidney’s cGMP site. Reporting to the VP of Quality, this role manages daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with Manufacturing, Quality Control, Supply Chain, and Facilities to maintain a state of control on the production floor.

Responsibilities

• Manage, develop, and coach the QA On-The-Floor team; ensure training, qualification, and performance expectations are met.
• Assign and approve work performed by direct reports, including documentation reviews and floor support activities.
• Maintain team readiness by ensuring all OTF personnel remain gown-qualified and trained on current procedures.

Manufacturing Floor Support & Quality Oversight

• Oversee and publish daily/weekly QA floor support schedules aligned with the manufacturing schedule.
• Provide real-time QA presence on the manufacturing floor, including routine walkthroughs, observation of operations, support during processing, and reinforcement of cleanroom behaviors.
• Identify, document, and escalate GMP issues or atypical events during manufacturing.
• Perform and/or oversee real-time batch record review to ensure accuracy and completeness.

Quality Decision Making & Issue Resolution

• Make routine QA decisions related to room/equipment release, line clearance, and documentation accuracy.
• Support and/or approve alarms, return-to-service documentation, deviations, change controls, and other quality records related to floor operations.
• Partner with Manufacturing to troubleshoot operational issues and implement corrective actions.

Documentation & Compliance Activities

• Ensure timely review of GMP documents (forms, logbooks, testing documentation, alarms, kitting, etc.).
• Ensure quarantined materials are stored and managed appropriately post-manufacturing.
• Author, revise, and review SOPs and quality procedures related to on-the-floor operations.
• Support internal audits, regulatory inspections, and compliance initiatives.

Cross Functional Collaboration

• Collaborate in a fast-paced, matrixed environment to ensure alignment on quality expectations and operational priorities.
• Participate in cross-functional quality teams and process improvement initiatives.

Other Responsibilities

• Maintain standards for accurate documentation, data integrity, and compliance in all QA-OTF activities.
• Perform other duties as assigned.
• Education And Experience:
• Bachelor’s degree in applied science or related field.
• 5+ years relevant QA experience in cGMP aseptic manufacturing, preferred as Quality on the floor
• Demonstrated knowledge of commercial GMP regulations for Sterile manufacturing.
• Strong organizational, analytical, and time management skills.
• Ability to work well in a team environment with positive attitude.
• Excellent communication skills with strong attention to detail.
• Ability to handle multiple tasks simultaneously.
• Demonstrated working knowledge of FDA, EU, and ICH regulatory requirements.
• Physical ability to perform frequent tasks requiring strength and mobility.

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.

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