Impactful Assay Validation & Data Analyst

biotechne; Minneapolis (MN); On-site; USD 56,000 - 91,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan

Employee stock purchase plan (ESPP)

HSA/FSA

Tuition reimbursement

Mentorship programs

Job summary

Bio-Techne seeks a skilled professional to manage assay value assignment and data validation, ensuring alignment with release specifications. You will compile validation data, write SOPs, and support QA and regulatory teams in creating validation summaries and reports.

The role requires 3–5 years in a lab or QA setting and a BS in Medical Technology or Biological Sciences, with hematology experience preferred. This is a full-time, on-site position in Minnesota.

Qualifications

• This position requires a BS degree in Medical Technology or Biological Sciences or equivalent combination of education and related clinical laboratory experience.
• 3-5 years of related experience in a lab or quality assurance setting.
• Experience in Hematology preferred.

Responsibilities

• Perform assay value assignment.
• Perform calculations and prepare assay sheet data for entry into templates.
• Maintain product history for value assignments and monitor assay values.
• Maintain knowledge of instrument theory and methodology.
• Write and maintain Assay Office procedures for value assignment and related procedures.
• Collaborate with Product Validation Manager to write and review validation summaries and reports.
• Review Product Finishing and Laboratory records and completes release documents.
• Maintain Batch Records.
• Prepare COAs for OEM customers and review all copies.
• Proofread Certificates of Analysis (COAs) and assay sheets.
• Coordinate customer data and QC laboratory testing.
• Assist with calibration decisions for internal analyzers during whole blood calibration.
• Prepare validation documents per SOPs and Quality SOPs.
• Collaborate with QA and Regulatory Affairs on validation summaries and reports.

Skills

Laboratory equipment

Company procedures

Customer service

Problem solving

Independent work

Project coordination

Multitasking

Communication

Attention to detail

Teamwork

Time management

MS Word

Excel

Typing

Education

BS degree in Medical Technology or Biological Sciences

Job description

Bio-Techne seeks a skilled professional to manage assay value assignment and data validation, ensuring alignment with release specifications. You will compile validation data, write SOPs, and support QA and regulatory teams in creating validation summaries and reports.

The role requires 3–5 years in a lab or QA setting and a BS in Medical Technology or Biological Sciences, with hematology experience preferred. This is a full-time, on-site position in Minnesota.