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Quality Assurance (QA) Technician

Localisation: Salt Lake City, UT, États-Unis
Type de Contrat: Unfixed Term
Fonction: Quality

Description

Job Summary
The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Calibration & Preventive Maintenance, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.

This is an entry-level position. Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventive maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected.  This position regularly interacts and collaborates with other departments within the company.

Essential Job Duties and Responsibilities

  1. Perform all work in compliance with company policy and within the guidelines of its Quality System.
  2. Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
  3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
  4. Verify documentation (DHR Review) and upload to BioFire Diagnostics Quality System.
  5. Follow work instruction documents to ensure batch record compliance
  6. Perform visual inspection on completed instruments
  7. Provide support for compliance of preventative maintenance and calibration requirements of manufacturing equipment.
  8. Verification of GMP standards; eg. Adherence to cGMP procedures and processes
  9. Perform eSMI visual inspection
  10. Identify any/all non-compliance to batch records, work instruction documents, and calibration requirements
  11. Alert manager of nonconforming events
  12. Identify opportunities for process improvement.
Supplemental DataMinimal domestic travel may be required for training purposes.

Training and Education
  1. High school diploma or equivalent is required
  2. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is preferred
Experience
  1. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
  2. Experience in Quality Assurance or Quality Control, laboratory or life science manufacturing setting that has a formal quality system is preferred.
Knowledge, Skills, and Abilities
  1. Effective written and verbal communication skills
  2. Proficiency in MS Office tools, including Outlook, Word, and Excel
  3. General computer operation
  4. Attention to detail is fundamental to this position.
  5. Ability to accurately follow written and verbal instructions.
  6. Organization skills as needed to maintain paperwork and task schedule.
  7. Proficiency in internet navigation
  8.  Basic math proficiency
Physical Requirements
  1. Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
  2. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if necessary).





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