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Quality Assurance (QA) Technician

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Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality

bioMerieux logo

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

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.

 

Responsibilities:

  • 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.
  • Verify documentation (DHR review) and upload to BioFire Diagnostics Quality System.
  • Ensure good documentation practices during document review.
  • Conduct floor sweeps (entails verification of GMP standards)
  • Follow work instruction documents to ensure batch record compliance.
  • Create Non-Conformance Reports for failing product.
  • Conduct In-Process inspections.
  • Conduct software verifications.
  • Conduct subassembly inspections.
  • Provide support for compliance of preventative maintenance and calibration requirements of manufacturing equipment.
  • Identify any/all non-compliance to batch records, work instruction documents, and calibration requirements
  • Alert management of nonconforming events.
  • Other duties depending on sub-unit

 

Qualifications

Training and Education

  • High school diploma or equivalent is required
  • Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is preferred

 

Experience

  • Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
  • 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

  • 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

 

Physical Requirements

  • Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
  • 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).

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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