Advanced Assay Office/Validation Analyst

Bio-Techne • Minneapolis, MN

4d • $55,600 - $91,450 • Onsite

About The Position

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.

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.

Requirements

• 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.
• 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.

Nice To Haves

• Experience in Hematology preferred.
• Knowledge of CLSI EP05 and ISO 13485 is desired.

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.

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans
• employee stock purchase plan (ESPP)
• Health Saving Account (HSA)
• Flexible Spending Account (FSA)
• Dependent Care FSA
• mentorship
• promotional opportunities
• training and development
• tuition reimbursement
• internship programs
• employee resource groups
• volunteer paid time off
• employee events
• charity drives
• accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level