Quality Assurance Specialist 1, Batch Release Contractor
About The Position
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. The position builds foundational knowledge of cGMP requirements, data integrity, quality systems, and batch release processes. This is a contractor position located onsite in Winston Salem, North Carolina. It is not eligible for ProKidney benefits and is not eligible for remote or hybrid work. Flexibility and overtime may be required as business needs dictate.
Requirements
- Bachelor’s degree in life sciences, engineering, quality, or a related field; alternatively, 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.
- Must be eligible to work in the United States without the need for work visa or residency sponsorship.
Nice To Haves
- Exposure to electronic quality or document management systems.
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.
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What This Job Offers
Career Level
Entry Level
