QC Specialist

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.Bio-Techne’s Diagnostics Division has been providing essential products to the in vitro diagnostics industry for over 40 years. We supply quality controls and reagents for clinical laboratory and point-of-care testing, along with custom products to other companies serving the IVD market.Full compensation for this position is $52,000 - $96,800 + annual bonus program and complete benefits package.Position Summary:Responsible for performing QC testing for Value Assignment assays, QC release assays, stability, physical/visual inspections, any related QC function. Assists in the flow of product in the QC department.Key Responsibilities:Coordinate, perform and maintain QC testing and scheduling for Stability programAssist in establishing QC specificationsAssist in the validation testing of equipment and processesAssist in the review and creation of ISO/QSR documentationPerform QC assay testing for release of final productPerform assay testing for Value Assignment, complaints and date extensionsPerform physical/visual inspectionsPerform Quality Control inspection, testing and disposition of incoming raw materials as neededPerform area line clearances for packaging and shipping as neededCreating and maintaining documentation to perform QC Release testing and any related QC functionAssist in maintaining systems to ensure that all products meet the required specificationsPerforms analysis and interpretation of test results, identifies deviations, and makes appropriate recommendationsProvides guidance to QC staff and applies technical knowledgeWrite Standard Operating Procedures (SOP’s) when appropriateInitiate Non-Conforming Material Reports when appropriateInitiate change order forms when appropriateProvides training to company personnel as neededPerform environmental monitoring, bioburden, weight checks as neededPerform equipment calibration including maintenance of calibration schedule as neededMaintain retain program including sample acquisition and tracking as neededSpecial projects as assignedPerform additional functions as requiredEducation and Experience:Bachelor’s degree in Biological Science, Chemistry, or related field. Experience with assays on automated assay systems preferred. 1- 5 years’ work experience in In Vitro diagnostics, medical device, pharmaceutical or related industry required.Knowledge, Skills and Abilities Required:Ability to show initiative and to perform in a multi-task environmentGood interpersonal and verbal/written communication skillsAbility to work with personnel of all levelsKnowledge of QSR and ISOTechnical writing capabilityDetail orientedWhy 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.