Job Information
Bio-Techne QC Specialist in San Marcos, California
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 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 (SOP’s) 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:
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 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 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.
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.
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.