Assay Office Associate

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:

Assay Office Associate, Diagnostic Reagent Division Clinical Controls.

The responsibilities of this position include all aspects of assay value assignment. Responsibilities include organizing, analyzing, and evaluating internal and external data for the assignment of assay values comparing selected assay values to release specifications. Assists Assay Office Supervisor in maintaining Assay Office procedures. Responsible for schedule and management of reference labs and CAP early vials, coordinating Eurocell data and QC file testing, and responsible for creating the weekly lab schedule. Perform additional duties as assigned.

Key Responsibilities:

• Organizing, analyzing, and evaluating internal and external data for the assignment of assay values comparing selected assay values to release specifications. Performs assay value assignment. Reviews Product Finishing and Laboratory records and completes release documents. Maintains Batch Records.
• Proofreading COA’s, assay and instruction sheets, box labels, product labels and other proofing as needed.
• Performs appropriate calculations and prepares assay sheet data for entry into assay sheet templates. Prepares certificates of Analysis for OEM customers. Reviews all copies.
• Maintains reference lab schedules and spreadsheets.
• Generates weekly lab schedule for Lab Supervisor.
• Coordinates Eurocell data and testing.
• Oversees work of QC technical and clerical staff involved with value assignment to ensure accuracy of values.
• Writes and maintains Assay Office procedures for value assignment and related procedures.
• Maintains product history used for value assignment and monitors quality of assay values.
• Maintains knowledge of instrument theory and methodology.
• Helps review Raw Data and Day Log daily. Corrects errors and resolves any discrepancies so data is collected to the appropriate QC sheets.
• Assists with calibration decisions of internal analyzers.
• Resource for other departments and QC laboratory staff.
• Participates in quality audits of hematology operations.
• Maintains confidentiality of records, data, and other information relating to the company’s interests.
• Follows 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.
• Performs additional duties as assigned.

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.
• Experience in Hematology preferred.
• Good communication skills, data analysis skills, and computer skills required. Working knowledge of Microsoft Word and Excel are required. Computer entry and/or typing skills are desirable. Must be able to work in a fast-paced environment, multi task, and have good communication skills, both verbally and in writing.

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

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
• We help our employees develop their careers through mentorship, promotional opportunities, training and development, 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 foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.

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.

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