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KCAS BioPosted 1 month ago

Technicien en Contrôle Qualité (CQ)

On-siteLyon, Auvergne-Rhône-Alpes, France

Full TimeMedium

Job Summary

Receive, record, and track samples and reagents while managing Watson database entries and specimen listings. Draft and review correction requests for sponsors and study directors, then resolve discrepancies with project leads. Verify data integrity, experiment preparation documents (COAs, MOs, protocols), and reagent/sample calculation sheets. Evaluate internal control results, including concentration, standard curves, and QC metrics, to determine necessary actions. Report out-of-specification results, deviations, equipment calibration issues, and training gaps. Examine compiled reports prior to release to ensure adherence to data management specifications and validity criteria. Conduct sample, reagent, and raw material inventories while coordinating returns and shipments. Participate in project tracking meetings and implement study controls within deadlines. Support technical teams with physical inventory, documentation, and filing. Prepare for internal, client, and regulatory audits, CAPA, and investigations. Maintain knowledge of GLP/GCP regulations and ICH M10 guidelines.

Required Qualifications

  • Niveau d'étude Bac +2 à Bac +3
  • Technicien laboratoire/Assistant Contrôle Qualité
  • Bonne capacité de communication écrite et orale en anglais et en français
  • Soucieux du détail et rigoureux
  • Bonnes compétences en informatique
  • Connaissance pratique de Microsoft Office, y compris les applications PowerPoint, Word, Teams et Excel
  • Très fort sens de l'organisation, autonomie, anticipation et réactivité, gestion des priorités
  • Aisance relationnelle, esprit d'équipe
  • Bonnes aptitudes de communication, clarté et précision

Desired Qualifications

  • Une expérience préalable a des outils informatiques type eQMS, LIMS et ELN serait un atout
  • Une expérience préalable dans un environnement GxP (BPL, GcLP, BPC, etc.......) serait utile

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