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Quality Floor Support - 3rd shift

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

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.

 

Position Summary:

The Quality Floor Support (QFS) Specialist 1 is responsible for providing quality oversight and guidance on the production floor. In this capacity, they identify and resolve exceptions in production areas and review data and records for GMP compliance.

 

The QFS Specialist 1 routinely performs and documents walkthrough audits of bioMérieux production, warehouse and support areas.  They support quality continuous improvement and investigation activities, including but not limited to customer complaints, nonconformance investigations and CAPAs.

 

Responsibilities:

  • Documents and communicates quality observations made during production facility walk-through audits.
  • Initiates In-Process Events (IPEs) and collects all associated documentation; reviews and approves AQL packets.
  • Opens nonconformance initiation records in TrackWise and attaches all relevant supporting documentation.
  • Reviews manufacturing logbooks and documentation on-the-floor for BacT/ALERT products to make sure they are complete, filled out correctly and entries comply with BMX controlled documentation procedures. 
  • Provides training to manufacturing personnel on open waivers and rework as needed to support product release.
  • Ensures MFG areas post construction/cleaning are back in a validated state and authorizes the release of production areas.
  • Completes continuous improvement projects, as assigned.
  • Revises SOPs, job aids, forms and attachments as part of change control process, as assigned.
  • Supports internal/external audits, as needed.
  • Performs final product AQL Inspections and assists with training new AQL inspectors, as needed.
  • Provides on-call weekend quality support for BioMérieux production activities.
  • When responding to quality issues in the BioMérieux production, warehouse and support areas, the QFS Specialist 1 is authorized to make decisions that result in corrective actions and segregation of product.

 

Studies and Experience:

  • Associate’s degree in a field related to science, technology, engineering or mathematics is preferred.
    • 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.  
  • 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.

 

Skills and Qualifications:

  • 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.
  • Demonstrates the ability to become familiar with relevant domestic and international regulations and industry standards (e.g. ISO, FDA, IVDR, QSR).
  • Strong interpersonal skills and ability to work with all levels of an organization.
  • 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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