Position Summary
The Quality Assurance Specialist I, Batch Release performs routine review and administrative activities that support material and product disposition. Working under established procedures and regular guidance, the role reviews executed manufacturing and laboratory documentation for completeness, accuracy, and compliance; records review status; identifies discrepancies; and escalates issues to more experienced Quality personnel. This position builds foundational knowledge of cGMP requirements, data integrity, quality systems, and batch release processes.
This is a contractor position and will not be eligible for ProKidney benefits. This position is located onsite in Winston Salem, NC and is not eligible for remote or hybrid work. This position will require flexibility and overtime as needed depending on the needs of the business.
Essential Duties and Responsibilities
- Review routine executed manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.
- Verify documentation for completeness, legibility, traceability, required signatures, calculations, and adherence to data integrity expectations.
- Identify documentation discrepancies, communicate findings, and escalate potential compliance or release-impacting issues.
- Compile batch disposition documentation and confirm required records are available for review.
- Enter and maintain accurate batch review status, deficiencies, and follow-up actions in approved GMP systems and trackers.
- Support follow-up on missing information, corrections, and documentation responses with Manufacturing, Quality Control, and Supply Chain.
- Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.
- Perform routine production-area observations and promptly report potential cGMP concerns.
- Complete required training, maintain current knowledge of assigned procedures, and participate in continuous improvement activities.
- Perform other quality-related duties as assigned.
Minimum Qualifications
- Bachelor’s degree in life sciences, engineering, quality, or a related field; or an associate degree with at least two years of relevant experience in a regulated environment. An equivalent combination of education and experience may be considered.
- Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.
- Ability to follow detailed procedures, recognize documentation errors, and escalate concerns appropriately.
- Strong attention to detail, organization, and written and verbal communication skills.
- Ability to manage routine priorities, meet deadlines, and work effectively with guidance.
- Proficiency with Microsoft Word and Excel; exposure to electronic quality or document management systems preferred.
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.