The QA Specialist 2 provides essential Quality Assurance support to Quality Operations, with a primary focus on material and batch release activities. Working within established GMP processes and under moderate supervision, this role contributes to maintaining compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. The successful candidate applies developing professional knowledge, strong attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities in a fast-paced pharmaceutical environment.

Key Responsibilities

GMP Database & Documentation Support

• Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases under established procedures
• Prepare and conduct initial reviews of batch and material release documentation, ensuring conformance with applicable SOPs, specifications, and acceptance criteria
• Evaluate completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and company requirements; escalate discrepancies to senior QA staff
• Report key quality metrics and performance indicators as required, using established templates and reporting tools

Production Monitoring & Product Compliance

• Perform hands-on monitoring of production and non-production activities; identify and report observed non-compliance to Quality Management in a timely manner
• Support confirmation that finished products conform to government and company standards and meet cGxP regulations
• Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management

Deviation & CAPA Support

• Assist in investigating deviations under the guidance of senior QA staff; contribute to root cause identification and propose corrective actions for review and approval
• Identify compliance risks and effectively communicate observations to senior management; support the implementation of assigned action plans to mitigate risks
• Promptly escalate critical quality issues to senior management with relevant documentation and context

Quality System & Procedure Support

• Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies, as assigned
• Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management
• Assist in the implementation and maintenance of regulated Quality Systems under the direction of senior QA personnel

Collaboration & Professional Development

• Collaborate with internal departments to support the implementation of quality principles and regulatory requirements
• Maintain up-to-date knowledge of industry trends, standards, and methodologies related to cGxP and GMP through continuous learning
• Apply developing technical and analytical skills while building professional judgment and deepening subject matter knowledge

Qualifications

Education/Experience

• Associate’s Degree + years of relevant experience in a GMP-regulated environment, OR Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, or a related field + 2 years of relevant experience in a GMP-regulated environment

Knowledge

• Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations
• Familiarity with deviation management and CAPA processes; experience participating in or supporting investigations preferred
• Basic familiarity with FDA, EU, and/or ISO regulatory frameworks preferred

Skills

• Communicates professionally, clearly, and concisely — both verbally and in writing — with internal and external stakeholders
• Strong attention to detail with the ability to maintain accuracy in documentation and data entry under defined processes
• Able to organize and prioritize assigned work effectively to meet timelines with quality deliverables
• Works collaboratively within a team environment; receptive to feedback and committed to continuous improvement
• Proficient with Microsoft Word, Excel, and Adobe; experience with electronic batch record or LMS systems a plus

Position Summary

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 in Winston Salem, NC 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.

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 managers 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.
This position is located fully onsite in Winston Salem, NC. 

Team Leadership & Oversight

• 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
• Proven, hands-on 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.