Advanced Assay Office/Validation Analyst

Location: Onsite in Minneapolis, MN, United States; standard business hours with occasional schedule variation based on production needs.

Salary: $55,600–$91,450 per year.

Company

hirify.global provides tools that support life sciences research and clinical diagnostics, enabling researchers to treat and prevent disease.

What you will do

• Perform assay value assignments, calculations, data analysis, and assay sheet preparation.
• Maintain product history, assay value quality, batch records, and release documentation.
• Collaborate with Product Validation, Quality Assurance, and Regulatory Affairs on validation summaries and reports.
• Review laboratory and product finishing records and prepare Certificates of Analysis for OEM customers.
• Coordinate customer data and QC laboratory testing, and assist with analyzer calibration decisions.
• Prepare validation documents and follow electronic documentation and quality-related SOPs.

Requirements

• BS degree in Medical Technology, Biological Sciences, or an equivalent combination of education and clinical laboratory experience.
• 3–5 years of related experience in a laboratory or quality assurance setting.
• Knowledge of laboratory equipment, data analysis, documentation, and quality procedures.
• Working knowledge of Microsoft Word and Excel, with strong computer entry and typing skills.
• Strong communication, organization, problem-solving, attention to detail, and multitasking abilities.
• Must be authorized to work in the United States without current or future visa sponsorship.

Nice to have

• Experience in hematology.
• Knowledge of CLSI EP05 and ISO 13485.

Culture & Benefits

• Onsite work during standard business hours in a laboratory and office environment.
• Medical, dental, vision, life, disability, pet, and legal insurance benefits starting on day one.
• 401(k), employee stock purchase plan, HSA, FSA, and dependent care FSA.
• Mentorship, training, development opportunities, tuition reimbursement, and promotional opportunities.
• Paid holidays, paid time off, paid parental leave, volunteer paid time off, and employee resource groups.