QC Data Review Analyst (cGMP)

Location: Rensselaer, NY 12144, United States

Salary: $64,500 per year

Company

hirify.global provides staffing and employment services for regulated technical and life-science roles.

What you will do

• Review raw technical data from compendial and client-specific laboratory testing methods.
• Verify QC testing and laboratory operations against SOPs, cGMP requirements, and regulatory standards.
• Author, review, and approve QMS documentation, including change controls, SOPs, deviations, and CAPAs.
• Collaborate with laboratory personnel to maintain data accuracy, integrity, and compliance.
• Support raw material releases and GMP production-suite commissioning.
• Provide onboarding and training support and perform QA cleaning verifications when required.

Requirements

• Bachelor's degree in Chemistry or a relevant scientific field with 3+ years of related experience in a pharmaceutical, biotechnology, medical device, or cGMP FDA-regulated industry.
• Alternatively, a master's degree in Chemistry or a relevant field with at least 1 year of related industry experience.
• Strong knowledge of cGMP regulations, data integrity standards, technical data analysis, and laboratory compliance practices.
• Work location: Rensselaer, New York.

Culture & Benefits

• Equal opportunity employment with reasonable accommodation support.
• For temporary assignments lasting 13 weeks or longer: medical, dental, vision, 401(k), and statutory sick pay where required.
• Employment eligibility processes may include E-Verify in certain locations.