Quality Assurance Specialist 1, Batch Release Contractor

The role

The Quality Assurance Specialist I performs routine review and administrative activities to support material and product disposition. This role reviews manufacturing and laboratory documentation for completeness, accuracy, and compliance.

What you will do

• Review routine executed manufacturing, filling, packaging, labeling, and analytical records.
• Verify documentation for completeness, legibility, traceability, signatures, and calculations.
• Identify documentation discrepancies and escalate potential compliance issues.
• Compile batch disposition documentation.
• Enter and maintain batch review status and deficiencies in GMP systems.
• Support follow-up on missing information and corrections with other departments.
• Assist with deviation, investigation, CAPA, change control, and controlled-document activities.
• Perform routine production-area observations.
• Complete required training and participate in continuous improvement activities.
• Perform other quality-related duties as assigned.

Required 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.
• Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.
• Ability to follow detailed procedures, recognize documentation errors, and escalate concerns.
• 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.

Nice to have

• exposure to electronic quality or document management systems

Before you apply

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

About the company

ProKidney is an equal employment opportunity employer.