Advanced Assay Office/Validation Analyst

Research & Diagnostic Systems, Inc.; Minneapolis (MN); On-site; USD 56,000 - 91,000; Full time

Job summary

Bio-Techne is seeking a professional to perform assay value assignment and assist with product validation activities. You will organize, analyze, and evaluate data to assign assay values, compare values to release specs, and compile validation data for reports.

The role involves writing and maintaining procedures, collaborating with the Product Validation Manager on validation summaries, and ensuring proper documentation and record keeping.

Qualifications

• BS degree in Medical Technology or Biological Sciences or equivalent.
• 3–5 years of related experience in a lab or QA setting.
• Hematology experience preferred.

Responsibilities

• Perform assay value assignment.
• Prepare assay sheet data for templates.
• Maintain product history for value assignments.
• Coordinate with QA/Regulatory for validation summaries.
• Prepare COAs for OEM customers.
• Review and proofread proofs and records.
• Assist with calibration decisions for internal analyzers.

Skills

Data analysis

Communication

Problem solving

Attention to detail

Independent work

Education

BS in Medical Technology or Biological Sciences

Tools

Microsoft Word

Excel

Laboratory equipment

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 and Experience

• 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.

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.

Physical Requirements

Ability to work at a computer for extended periods. Ability to lift and handle materials weighing 5–20 lbs. Ability to work at a computer for extended periods. 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.

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.

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).

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.