Specialist I, QC Analytics (Wed-Sat Shift)

Location: Waltham, Massachusetts, United States; onsite lab-based role with a Wednesday–Saturday shift

Salary: $43–$57 per hour

Company

hirify.global is a technology-driven biotechnology company providing integrated technologies, end-to-end services, and manufacturing expertise for advanced therapies.

What you will do

• Support product release testing in the QC analytical laboratory for gene therapy programs.
• Transfer and qualify assays developed by Analytical Development.
• Draft and review methods, qualification procedures, validation procedures, and reports for cellular assays such as flow cytometry.
• Perform routine molecular and cellular analytical testing, then review, analyze, and communicate results.
• Investigate analytical testing excursions, deviations, CAPAs, and OOS events.
• Train laboratory staff and collaborate with QC functions to complete testing on schedule.

Requirements

• Bachelor’s degree in Biology, Chemistry, Microbiology, or a related technical discipline with at least 3 years of experience, or a Master’s degree with at least 1 year of experience.
• Required experience with PCR, flow cytometry, immunoassays, and cIEF; significant flow cytometry experience is strongly preferred.
• Knowledge of GMPs, SOPs, and quality system processes.
• Experience in a GMP QC laboratory and/or drafting test methods and qualification documents is strongly preferred.
• Strong organizational, communication, collaboration, and independent working skills.
• Experience with LIMS, CMMS, QMS, or ERP systems is a plus.

Culture & Benefits

• Regular employment in the Quality Control department.
• Cross-functional collaboration with Analytical Development and other QC functions.
• Work in a laboratory supporting advanced gene therapy programs.