Quality Assurance Coordinator

Location: Centennial, Colorado, USA

Salary: $85,000–$105,000 per year

Company

hirify.global is an international life sciences company providing analytical testing, laboratory, clinical diagnostics, pharmaceutical, environmental, food, and agroscience services.

What you will do

• Develop, implement, and maintain the laboratory quality management system, including the Quality Manual, policies, and procedures.
• Monitor compliance with CAP, CLIA, ISO 15189, GxP, FDA, and other applicable federal, state, and local requirements.
• Coordinate internal and external audits, inspections, client audits, findings, corrective and preventive actions, and closure verification.
• Control quality documentation and records, including nonconformances, deviations, incidents, change requests, and objective evidence.
• Support investigations, root cause analysis, risk mitigation, staff training, QA meetings, and quality-related communications.
• Maintain the Approved Supplier List and coordinate supplier qualification, requalification, and vendor-related SCAR documentation.

Requirements

• Bachelor’s degree in chemical, physical, biological science, Medical Laboratory Science, or a related field from an accredited institution.
• 5–7 years of experience in a clinical or analytical laboratory, including quality assurance or quality control experience.
• Strong knowledge of quality management systems and laboratory standards, including ISO, CLIA, and CAP.
• Experience with LIMS and Microsoft Office Suite.
• Excellent attention to detail, organization, analytical reasoning, problem-solving, and written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Nice to have

• Certified Quality Auditor or Six Sigma certification.
• Experience with ASHI, CAP, CLIA, or other laboratory certifications relevant to the specialty.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) plan with company match.
• Paid vacation and holidays.
• Work in a global, decentralized network of laboratories and life sciences professionals.