QC Specialist

Bio-Technes 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 hourly range for this position is $23.20 - $34.80 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 program
• Assist in establishing QC specifications
• Assist in the validation testing of equipment and processes
• Assist in the review and creation of ISO / QSR documentation
• Perform QC assay testing for release of final product
• Perform assay testing for Value Assignment, complaints and date extensions
• Perform physical / visual inspections
• Perform Quality Control inspection, testing and disposition of incoming raw materials as needed
• Perform area line clearances for packaging and shipping as needed
• Creating and maintaining documentation to perform QC Release testing and any related QC function
• Assist in maintaining systems to ensure that all products meet the required specifications
• Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations
• Provides guidance to QC staff and applies technical knowledge
• Write Standard Operating Procedures (SOPs) when appropriate
• Initiate Non-Conforming Material Reports when appropriate
• Initiate change order forms when appropriate
• Provides training to company personnel as needed
• Perform environmental monitoring, bioburden, weight checks as needed
• Perform equipment calibration including maintenance of calibration schedule as needed
• Maintain retain program including sample acquisition and tracking as needed
• Special projects as assigned
• Perform additional functions as required
• Education and Experience :

Bachelors 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 environment
• Good interpersonal and verbal / written communication skills
• Ability to work with personnel of all levels
• Knowledge of QSR and ISO
• Technical writing capability
• Detail oriented
• 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.

Salary : $23 - $35