QC Specialist (LIMS)

Location: US - Rhode Island - West Greenwich; onsite role

Salary: USD 100,450.45–135,903.55 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Serve as the Quality Control Systems subject matter expert and business process owner for Sample Manager LIMS and related laboratory computerized systems.
• Support the full lifecycle of laboratory systems, including design, configuration, implementation, validation, maintenance, upgrades, and retirement.
• Maintain QC systems in compliance with GMP, 21 CFR Part 11, data integrity requirements, and hirify.global's Quality Management System.
• Configure and approve LIMS templates for sample plans, specifications, metrics, trending, and new product introductions.
• Support laboratory data retrieval, reporting, investigations, audits, regulatory inspections, change management, and inspection readiness.
• Partner with Manufacturing, Process Development, Engineering, Information Systems, Supply Chain, and Global Quality while training and mentoring laboratory users.

Requirements

• Doctorate degree; or a master's degree and 2 years of relevant experience; or a bachelor's degree and 4 years; or an associate's degree and 8 years; or a high school diploma/GED and 10 years of quality, quality systems, or quality control experience.
• 5+ years of experience in pharmaceutical or biotechnology Quality Control, Quality Assurance, or Quality Systems is preferred.
• Experience with Laboratory Information Management Systems, preferably Sample Manager LIMS, and computerized laboratory platforms such as Empower, ELN/LMES, Veeva, Kneat, or ALM.
• Knowledge of GMP regulations, 21 CFR Part 11, data integrity principles, laboratory operations, analytical testing, sample management, and QC workflows.
• Experience with system implementation, lifecycle management, SOPs, sample plans, validation documentation, work instructions, audits, and regulatory inspections.
• Strong technical writing, communication, collaboration, analytical, organizational, and problem-solving skills; SQL, reporting tools, or laboratory data analytics experience is preferred.

Culture & Benefits

• Collaborative, innovative, and science-based working environment focused on serving patients.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Annual bonus program, award-winning time-off plans, and career development opportunities.
• Flexible work models may be available where applicable to the role.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship is not guaranteed.