Senior Quality Assurance Technician

2 weeks ago

Salt Lake, Utah, United States bioMerieux Inc. Full time


Senior Quality Assurance Technician - Night Shift

Location: Salt Lake City, UT, United States

Position Type: Unfixed Term

Job Function: Quality

bioMerieux, a leader in the in vitro diagnostics industry for over 60 years, delivers diagnostic solutions that identify the origins of diseases and contamination, enhancing patient health and ensuring consumer safety.

With a workforce of over 6,200 across 11 sites in North America, including BioFire Diagnostics in Salt Lake City, we invite you to become part of our family-owned global organization, known for its long-term vision and human-centered culture.

Position Overview

As a Senior Quality Assurance Technician, you will be an integral part of the SLC Quality Assurance (QA) department, which provides comprehensive Quality support across various sectors. This role is situated within the Reagents Manufacturing Quality Assurance team, where your primary responsibilities will include reviewing quality documentation and inspecting manufactured products, while also contributing to additional quality functions as needed. Your work will be expected to be timely and precise, requiring regular collaboration with other departments.

Key Responsibilities

  1. Execute all tasks in alignment with company policies and the established Quality System.
  2. Review, evaluate, and monitor processes and products to ensure adherence to requirements.
  3. Contribute to other Quality Assurance subunits as assigned.
  4. Inspect products (including labels) against specifications and established protocols, determining acceptance status post-inspection.
  5. Identify and escalate any non-conformances detected during inspections, collaborating with production teams to address these issues.
  6. Maintain rigorous documentation practices during quality record reviews, reporting any discrepancies to the appropriate systems.
  7. Physically release work in progress for final goods processing.
  8. Organize and archive quality records in accordance with established procedures.
  9. Prioritize product releases to meet departmental objectives.
  10. Manage materials suspected of being non-conforming, both physically and electronically.

Qualifications

Education:

  1. High school diploma or equivalent is mandatory.
  2. An associate degree (or higher) in a life science or engineering discipline is preferred.
  3. Familiarity with good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is advantageous.

Experience:

  1. A minimum of 1 year of relevant on-the-job experience demonstrating professional communication skills.
  2. At least an additional year of experience in a Quality Assurance, Quality Control, laboratory, or manufacturing environment with a formal quality system. Education or certification in Quality Management Systems may substitute for this experience.

Skills and Abilities:

  1. Strong written and verbal communication skills.
  2. Proficiency in MS Office applications, including Outlook, Word, and Excel.
  3. General computer proficiency.
  4. Meticulous attention to detail is essential.
  5. Ability to accurately follow both written and verbal instructions.
  6. Organizational skills to manage paperwork and task schedules effectively.
  7. Basic math skills.

Physical Requirements:

  1. Capability to push, pull, bend, and/or lift at least 25 lbs, with potential to lift up to 50 lbs for extended periods.
  2. Ability to sit or stand for moderate durations and focus on computer screens for extended periods.
  3. Willingness to travel minimally for training purposes if necessary.
  4. Must be able to perform duties while wearing a Powered Air Purifying Respirator (PAPR) as required.
  5. Ability to work in a clean room environment, utilizing company-provided attire.

bioMerieux 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.

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