QA Specialist 2, Batch Release Contractor at PROKIDNEY – Winston-Salem, North Carolina

Winston-Salem, North Carolina, United States
Position Title: QA Specialist 2, Batch Release Contractor

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

• Associates Degree + years of relevant experience in a GMP-regulated environment, OR Bachelors 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