QC Specialist 1
Job Details
Experienced
San Marcos - San Marcos, CA
Full Time
2 Year Degree
None
Day
Description

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.

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

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
Qualifications

Education and Experience:

  • Bachelor’s degree in Biological Science, Chemistry or related field.  Experience with assays on automated assay systems preferred. 1- 2 years work experience in In Vitro diagnostics, medical device, pharmaceutical or related industry required.
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