QC Analyst II/III Reviewer (Biotech)

TL;DR

QC Analyst II/III Reviewer (Biotech): Performing quality control review of release, stability, and in-process testing documentation for gene therapy products with an accent on GxP compliance and data integrity. Focus on verifying analytical data for assays such as qPCR, Potency, and ELISA to ensure adherence to cGMP standards in a clinical-stage environment.

Location: Must be based in Redwood City, CA (On-site)

Company

hirify.global is a clinical-stage gene therapy company focused on developing functional cures for ocular diseases to restore vision and prevent blindness.

What you will do

• Perform QC review of release, stability, and in-process testing documentation to ensure GxP compliance.
• Analyze and verify analytical data for drug substance and finished products to ensure data integrity.
• Provide technical expertise in the review of analytical methods and troubleshooting for qPCR, Potency, ELISA, and SEC techniques.
• Support the revision and continuous improvement of QC procedures and SOPs.
• Identify, document, and manage deviations, including root cause analysis and corrective actions.
• Support qualification and validation activities through protocol and report review.

Requirements

• Bachelor’s degree in biology, chemistry, biochemistry, or a related field.
• 3-5 years of experience in a bio-pharma analytical laboratory setting.
• Proficiency in QC review of analytical documentation and laboratory software like Empower or SoftMax Pro.
• Strong understanding of cGMPs and regulatory requirements in the biotechnology sector.
• Experience reviewing analytical methods and raw data for techniques such as Potency, qPCR, SEC, and SDS-PAGE.
• Must be able to work on-site in Redwood City, CA.

Nice to have

• Experience with viral vector (adeno-associated virus) products.
• Solid foundation in molecular biology.
• Familiarity with statistical methods for experimental data analysis.

Culture & Benefits

• Opportunity to work on cutting-edge gene therapy platforms.
• Collaborative environment within a clinical-stage biotechnology company.
• Focus on professional growth and technical expertise development.