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Quality Control Specialist

Job Details

San Marcos, CA - San Marcos, CA
Full Time
Bachelor's Degree
Quality & Regulatory


By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.


Bio-Techne’s Diagnostic Reagents 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.

Compensation for this role is $18-32/hr + Bonus Eligibility.

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, tuition reimbursement, 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


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