Job Information
Bio-Techne Assay Office/Validation Associate in Minneapolis, Minnesota
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.
ESSENTIAL FUNCTIONS
Performs assay value assignment. Performs appropriate calculations and prepares assay sheet data for entry into assay sheet templates. Maintains product history used for value assignment and monitors quality of assay values. Maintains knowledge of instrument theory and methodology. Writes and maintains Assay Office procedures for value assignment and related procedures. Collaborates with Product Validation Manager to write and review validation summaries and reports. Reviews Product Finishing and Laboratory records and completes release documents. Maintains Batch Records. Prepares COAs for Original Equipment Manufacturer (OEM) customers. Reviews all copies. Proofreading Certificates of Analysis (COAs), assay sheets, and other proofing as needed. Coordinates customer data and QC laboratory testing. Helps review Raw Data and Day Log. Corrects errors and resolves any discrepancies so data is collected to the appropriate QC sheets. Assists with calibration decisions for internal laboratory analyzers during whole blood calibration. Prepares 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. Collaborates with Quality Assurance and Regulatory Affairs on validation summaries and reports. 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.
JOB SPECIFICATIONS
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.
EDUCATION & 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 required. Must be able to work in a fast-paced environment, multitask, and have good communication skills, both verbally and in writing.
Why Join Bio-Techne:
We offer competitive wages along with extensive benefits for employees and their families.
We invest in our employees’ financial futures through retirement programs 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 an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that 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.
Bio-Techne is an E-Verify Employer in the United States.
Bio-Techne is an Equal Opportunity Employer. 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.
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.
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