QA Specialist 2, Batch Release Contractor

ProKidney•Winston-Salem, NC

19h

About The Position

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.

Requirements

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
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
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
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Nice To Haves

experience with electronic batch record or LMS systems a plus

Responsibilities

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
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
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
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
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