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Quality Floor Support - 3rd shift

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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 that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

Position Summary:

The Quality Floor Support (QFS) specialist is responsible for providing quality oversight and guidance on the production 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. 

      

The QFS Specialist 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:

  • Facilitates decision making and corrective actions for quality observations made during production facility walk-through audits.
  • Initiates, reviews and approves In-Process Event (IPE) documentation, AQL packets and autoclave alarm response forms.
  • Opens nonconformance records in TrackWise.  Performs and authors nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.) as required.
  • Authors and reviews GMP documents including procedure revisions and specified reports, to support continuous improvement and the change control process.
  • Implements and completes continuous improvement projects as required.
  • Supports internal/external audits.
  • Performs final product AQL Inspections and assists with training new AQL inspectors, as needed.
  • Provides on-call weekend quality support for BioMérieux production activities, as needed.

 

Studies and Experience:

  • BA/BS degree in a science or engineering field OR an Associate’s Degree with a minimum of  3 years of progressively responsible and related experience working in a FDA regulated, GMP production facility.
  • Experience working in an FDA regulated, GMP environment with knowledge of Good Documentation Practices is required.

 

Skills and Qualifications:

  • Exhibits strong analytical and problem-solving skills.  Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize Quality Engineering tools and techniques effectively.
  • Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
  • Strong interpersonal skills and ability to work with all levels of an organization.
  • PC skills, including proficiency in: Microsoft Excel, PowerPoint and Word.
  • Prior knowledge of SPC and SAP preferred.

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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