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Product Labeling and Documentation Support Specialist

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Product Labeling & Documentation

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 Product Labeling and Documentation Support technician provides support to routine PLD within an operational hub.  They ensure the application of  processes necessary for the realization and delivery of product labeling deliverables (Instructions for Use, CD/DVD, labels, etc.) through conception and delivery. 

 

Main Accoutabilities:

  • Perform quality checks and verification of labeling deliverables.  Understand and ensure compliance to bioMerieux quality standards and regulations as they apply to labeling. 
  • Participate to the resolution of complaints, CAPA, and investigations. Represent PLD in the resolution of complaints and CAPAs.
  • Create PDFs and physical supports (DVD/CD/USB/Paper) in accordance with the project needs.  Publish labeling deliverables in Livelink, and the technical library. 
  • Act as PLD Document Control Authority (DCA) for PLD workflows and ensure the appropriate metadata.  Enter and verify labeling data into appropriate systems (SAP, PL-DMT, MDM)
  • Update documents and labels in legacy systems as needed.
  • Request quotations and follow-up on orders for PLD.
  • Prepare and provide files to translation providers and integrate translated files into the appropriate system on their delivery
  • Perform peer review and edit of documents written in English by non-native writers.
  • Process change requests related to labeling and provide support to PLD representatives and project teams as needed for labeling delivery.  Process the ECO in SAP.

 

Skills and Qualifications:

  • Associates degree in a related field (quality system, labeling, communication, information technology)
  • 3 years in labeling or quality system management
  • Knowledge of bioMerieux products and processes
  • Leadership and ability to communicate the needs/constraints of the department to contacts
  • Ability to work in a multi-cultural environment

 

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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