Advanced Assay Office/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

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range: $55,600.00 - $91,450.00

Position Summary

The responsibilities of this position include all aspects of assay value assignment and assisting with product validation activities. Responsibilities include organizing, analyzing, and evaluating internal and external data for the assignment of assay values comparing selected assay values to release specifications as well as compiling validation data for report generation.

Key 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.

Qualifications

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

Knowledge, Skills, and Abilities

• Knowledge of laboratory equipment.
• Knowledge of company procedures and practices.
• Skills in assisting customers in a professional manner.
• Skills in problem solving; including the ability to identify and appropriately evaluate a course of action.
• Ability to lead and act independently on routine assignments or projects.
• Ability to plan, organize and multi-task to complete assignments in an efficient manner.
• Ability to communicate professionally, both oral and written.
• Ability to pay attention to details and perform at a high-level accuracy.
• Ability to work independently and with a team.
• Ability to work hours that conform to standard business operations.
• Good communication skills, data analysis skills, and computer skills required.
• Working knowledge of Microsoft Word and Excel is required.
• Computer entry and/or typing skills are required.
• Must be able to work in a fast-paced environment and multitask.

Working Conditions

• Standard schedule hours with occasional variation depending on production needs.
• Onsite work required during standard business hours.
• Ability to work at a computer for extended periods.
• Ability to lift and handle materials weighing 5–20 lbs.
• Minimal physical demands beyond standard office requirements.

Why Join Bio-Techne

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Additional Information

Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status).

If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance.

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.