Senior Assay Validation Analyst

Bio-Techne Corp.; Minneapolis, Northern (MN, KY); Hybrid; USD 56,000 - 91,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k with company match

ESPP

HSA

FSA

Tuition reimbursement

Internship programs

Paid time off

Job summary

Bio-Techne Corp. is seeking a detail‑oriented laboratory professional to perform assay value assignments and assist with product validation. The role involves organizing and evaluating data, maintaining records, and preparing assay sheets and COAs for OEM customers.

You will collaborate with the Product Validation Manager, follow SOPs, and ensure accuracy in release documentation. Onsite in Minnesota, with a strong emphasis on quality and regulatory compliance.

Qualifications

• 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.
• Hematology experience preferred.

Responsibilities

• Perform assay value assignment.
• Perform appropriate calculations and prepare assay sheet data for entry into assay sheet templates.
• Maintain product history used for value assignments and monitors quality of assay values.
• Maintain knowledge of instrument theory and methodology.
• Write and maintains 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 Original Equipment Manufacturer (OEM) customers.
• Reviews all copies.
• Proofreading Certificates of Analysis (COAs), assay sheets, and other proofing as needed.
• Coordinate customer data and QC laboratory testing.
• Assist with calibration decisions for internal laboratory analyzers during whole blood calibration.
• Prepare validation documents in accordance with Bio-techne electronic documentation management system protocols.
• Follows applicable standard operating procedures (SOPs), including a good understanding of quality associated SOPs.
• Collaborate with Quality Assurance and Regulatory Affairs on validation summaries and reports.
• Knowledge of CLSI EP05 and ISO 13485 is desired.
• Maintain confidentiality of records, data, and other information relating to the company’s interests.
• Follow company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.
• Perform additional duties as assigned.

Skills

Lab equipment knowledge

Problem solving

Communication skills

Independent work

Attention to detail

Teamwork

Education

BS degree in Medical Technology or Biological Sciences or equivalent

Tools

Microsoft Word

Microsoft Excel

Job description

Bio-Techne Corp. is seeking a detail‑oriented laboratory professional to perform assay value assignments and assist with product validation. The role involves organizing and evaluating data, maintaining records, and preparing assay sheets and COAs for OEM customers.

You will collaborate with the Product Validation Manager, follow SOPs, and ensure accuracy in release documentation. Onsite in Minnesota, with a strong emphasis on quality and regulatory compliance.