Job Information
BioFire Diagnostics, LLC. Sr Quality Technician in Salt Lake City, Utah
he Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.
Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventative maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. This position builds upon the skills and responsibilities of a Quality Technician and requires an increased level of self-direction and motivation. This position regularly interacts and collaborates with other departments within the company.
Perform all work in compliance with company policy and within the guidelines of its Quality System.
Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
Other Duties
Effective written and verbal communication skills
Proficiency in MS Office tools, including Outlook, Word, and Excel
General computer operation
Attention to detail is fundamental to this position.
Ability to accurately follow written and verbal instructions.
Organization skills as needed to maintain paperwork and task schedule.
Proficiency in internet navigation
Basic math proficiency
Enter data into the CAL/PM software
Scan calibration certificates into the Cal/PM software
Perform Level 1 Calibrations (Pipette, Pressure, Calipers)
Perform second person verification of calibration
Escort suppliers into restricted areas to perform on-site calibration
Review and approve calibration and preventative maintenance forms
Perform contamination swabbing
Schedule vendor calibrations
Create NCR’s for out of calibration events
Respond to "out of tolerance" events
Respond to temperature monitoring alarms
Alert manager of equipment outside of its calibrated state
Alert manager of incomplete and inaccurate documents
Review and determine compliance of equipment within calibration requirements.
Review quality documents for completeness and accuracy
In-Process QC confirmation of new equipment and input of new items into CAL/PM software
Perform Level 2 Calibrations (Temperature, Freeze Dryer Temp, Scales, and Centrifuges)
Perform second user calibrations on pipettes
Under supervision can assist with daily sweeps of manufacturing areas to ensure cGMP
Perform Level 3 Calibrations (Freeze Dryer Pressure, Encoders, Torque, Multivac)
Review and approve calibration and preventative maintenance forms for production equipment.
Determine corrective actions for out of temperature events
Determine corrective actions for out of calibration events
Physical Requirements:
Be able to utilize various personal protective equipment (PPE), including respirators
Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be up to 50 lbs.
Training & Education Requirements: Not Applicable
Skills & Qualifications:
ASQ Certified Calibration Technician certification is a plus