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Quality Floor Support

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Position Summary:

In this role, you will be responsible for providing quality oversight and guidance on the manufacturing floor.  In this capacity, they authorize the release of production areas, identify and resolve exceptions in production areas and review data and records for GMP compliance, including MFG logbooks.  They make independent decisions on the production floor that result in corrective actions and appropriate segregation of product.   Quality Floor Support routinely performs and documents walkthrough audits of BioMérieux production, warehouse and support areas.  They support quality investigation activities, including but not limited to customer complaints, change controls, nonconformance investigations and CAPAs.  They provide assistance with CAPA effectiveness checks and complete assigned continuous improvement actions and projects with supervision.


Primary Duties:

  1. Ensures MFG areas post construction /cleaning are back in a validated state (cleaning, documentation).  Authorizes the release of production areas.
  2. Facilitates real-time decision making, issue resolution and corrective actions for quality observations made during production facility walk-through audits. Works with MFG to identify and reduce the risk of process/cleaning/equipment issues that could lead to customer complaints. 
  3. Initiates, reviews and approves In-Process Events (IPEs) in Trackwise. 
  4. Initiates nonconformance records in Trackwise and attaches relevant documentation.  Performs non-conformance investigations that do not have product impact with a co-author.  Demonstrates the appropriate use of quality management tools (5 why’s, Pareto analysis, 5M +E, Is/Is not).
  5. Reviews and approves AQL packets and autoclave alarm response forms.  Documents corrections to AQL packets and provides impact statements in comment sections.
  6. Revises SOPs, job aids, forms and attachments as part of the change control process as assigned. 
  7. Performs final product AQL inspections and assists with training new AQL inspectors as needed.  Provides training for MFG personnel and final AQL inspectors on open waivers and rework.
  8. Develops training PowerPoints and delivers presentations for manufacturing discrepancies during shift changeover meetings (procedural, gowning, organizational, refreshers).
  9. Provides on-call weekend quality support for final AQL and manufacturing operations.  For complex issues encountered while on-call, consults with management before implementing actions.


Studies, Experience, Skills and Qualifications:

  1. Associate’s degree in a field related to science, technology, engineering or mathematics is preferred
  2. In lieu of an Associate’s Degree, a high school diploma/GED with a minimum of ≥ 3 years of progressively responsible experience working in a regulated, GMP environment.  
  3. Candidates with GLP experience and university/college laboratory experience also considered.
  4. Exhibits both analytical and problem-solving skills.  Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing tasks.
  5. Experience working in a regulated, GMP environment and/or individuals with experience working in a GLP or college/university laboratory environment with knowledge of Good Documentation Practices is preferred.
  6. Demonstrates the ability to become familiar with relevant domestic and international regulations and industry standards (e.g. ISO, FDA, IVDR, QSR).
  7. Strong interpersonal skills and ability to work with all levels of an organization.
  8. PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.

 

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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