QC Specialist I, Logistics (Contract) (Biotech)

Location: Waltham, Massachusetts, United States; onsite work with laboratory, sample-handling, PPE, lifting, and other physical duties. Ability to work nights, weekends, and holidays as needed.

Salary: $43–$57 per hour

Company

hirify.global is a technology-driven biotechnology company providing integrated technologies, services, and manufacturing expertise for advanced therapies from design through commercialization.

What you will do

• Review protocols, data, and reports from contract testing laboratories supporting cell and gene therapy GMP production lots.
• Transfer incoming testing data into internal systems including LIMS and QMS, and review laboratory deviations and investigations.
• Coordinate sample shipments between contract manufacturing organizations, investigators, and contract testing laboratories.
• Manage QC sample submission, labeling, receipt, inventory, and related logistics.
• Write stability protocols, manage stability testing, trend data, and complete final reports.
• Author change controls and client documents, including sampling plans, specifications, and certificates of analysis, while communicating with clients and internal functions.

Requirements

• Bachelor’s degree with at least 3 years of experience, or a master’s degree with up to 1 year of experience.
• Degree or technical background in biology, chemistry, microbiology, engineering, or a related discipline, with experience in quality control, quality assurance, or GMP operations in biotechnology, biologics, or pharmaceutical manufacturing.
• Experience with cell and gene therapy methodologies including PCR, flow cytometry, ELISA/ELISpot, HPLC, and cell-based assays.
• Strong knowledge of GMP, SOPs, and quality system processes, including experience writing deviations, change controls, and corrective actions.
• Ability to communicate independently with scientific and technical personnel and maintain strong organizational skills.
• Ability to stand, walk, bend, stretch, lift 15–20 lb, use PPE, and perform repetitive physical work.

Nice to have

• Experience in a cell and gene therapy manufacturing environment.
• Experience performing laboratory investigations.
• Experience optimizing or troubleshooting laboratory experiments.

Culture & Benefits

• Work in a technology-driven biotechnology environment supporting advanced therapy development.
• Collaborate with contract laboratories, manufacturing organizations, investigators, clients, and internal cross-functional teams.
• Support daily operations across outsourced testing, sample management, stability programs, and quality systems.