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Supervisor, Quality Floor Support/QE, 3rd shift

Date: Nov 21, 2020

Location: Durham, NC, US

Company: bioMérieux

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. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.

 

Position Summary:

The 3rd shift QFS Group Lead is primarily responsible for ensuring that their shift provides on-the-floor quality guidance for manufacturing processes, product documentation review, product inspection, product segregation and corrective actions.  This is accomplished through the performance and documentation of routine quality walkthroughs in manufacturing areas including the warehouse and support areas to maintain a cGMP environment as well as representation at shift change-over and across department meetings. 

 

In this role, the 3rd shift QFS Group Lead works within the bioMérieux Quality Management System (QMS) to ensure the overall quality of manufactured products.  They perform, review and approve non-conformance investigations.  When conducting non-conformance investigations they show robust use of quality management tools (5 why’s, Pareto Analysis, 5M +E, Is/Is Not) in determining root cause.  They initiate and complete change controls to improve manufacturing processes and documentation.   

 

The 3rd shift QFS Group Lead enables their direct reports to support quality activities, including but not limited to customer complaints, nonconformance investigations, change controls and CAPAs.  They serve as quality representatives in the assessment of process issues and assist with improvement initiatives affecting manufacturing, inspection and quality system processes.  

Main Accountabilities:

  • Coordinates the activities of 3rd shift QFS personnel to provide solutions and corrective actions for quality observations in manufacturing areas.
  • Creates non-conformance and non-conformity records in TrackWise.  Performs nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not). Reviews and approves non-product impact nonconformance investigations.
  • Completes change controls to improve manufacturing, QA and QMS processes/documentation, as needed.
  • Initiates, reviews and approves In-Process Event (IPE) documentation.   
  • Trends and reports IPE events.  Performs quality walkthroughs of manufacturing areas and generates monthly QFS walkthrough and effectiveness check reports.  
  • Authors and approves GMP documentation including procedure revisions and specified reports, as needed. 
  • Ensures GMP data, logbooks and records are reviewed for compliance. 
  • Monitors assigns non-conformance investigations and change controls for on time closure and effectiveness. 
  • Coordinates on-call quality support for BioMérieux production activities, as needed.  
  • Performs final product AQL inspections and assists with training new AQL inspectors, as needed.  


Studies/Experience, Skills and Qualifications:

  • BA/BS degree in a science or engineering field or an Associate’s Degree with a minimum of ≥ 5 years of progressively responsible and related experience working in a FDA regulated, GMP production facility in lieu of Bachelor's Degree
  • 5+ years of experience working in a regulated environment with knowledge of Good Manufacturing Practices (GMP).
  • Minimum of three (3) years of experience involving team leadership and collaboration with multiple departments/functions.
  • Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
  • Must have strong verbal and written communication skills.  They demonstrate the ability to work well in a complex, diverse environment and can function independent of direct supervision.
  • Exhibits strong analytical, technical writing and problem-solving skills.  Clearly expresses ideas (verbal and written) and demonstrates competence in the selection and use of quality management tools and techniques.
  • Demonstrates ability to achieve bioMérieux non-conformance investigator and approver certification for product/process/facility issues.
  • PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
  • Prior knowledge of SPC and SAP preferred.
  • CQE or CQA certification through ASQ an asset.

 

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 11,200 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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Nearest Major Market: Durham
Nearest Secondary Market: Raleigh