Retour à la liste

QA Auditor I

Req ID #: 218990

Wilmington, Massachusetts, USA
Cet emploi est situé en dehors du pays / de la langue que vous avez sélectionné Français (Canada)

À propos de cet emploi

Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.   

  • Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions.  Communicate all identified compliance and quality risks to supervisor. 

  • Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.

  • Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures.

  • Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.

  • Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained.  May participate in the hosting of client site visits and support regulatory inspections.

  • Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings. 

  • Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.

  • Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.

  • Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.

  • Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.

  • Inspect materials and supplies for compliance with specifications.

  • Assist in providing basic regulatory training to operations personnel.

  • Assist in scheduling and tracking QA audits, inspections and procedures as requested.

  • Maintain written records for all statistical sampling and testing of product if tested in manufacturing areas.

  • Participate in manufacturing line clearances and verification of room acceptability prior to product manufacture.

  • Participate in Regulatory Affairs and Compliance projects.

  • Perform all other related duties as assigned.

CRL site

À propos de Charles River

Charles River est une organisation internationale de recherche de phase initiale sous contrat (ORC). Ici, nous sommes passionnés par notre rôle dans l'amélioration de la qualité de vie des gens. Avec 100 sites au travers le monde, nous sommes positionnés stratégiquement pour coordonner des ressources mondiales et appliquer des perspectives pluridisciplinaires à l'élaboration de solutions aux défis uniques de nos clients. Notre base de clientèle comprend des sociétés de biotechnologies et des laboratoires pharmaceutiques internationaux, des agences publiques, et des établissements hospitaliers, d'enseignement et de recherche partout dans le monde.

En savoir plus