Auditor I
CITOXLAB N.A. INC.
Laval, QC
ACCOUNTABILITY

Perform audits on studies, facilities, processes and validation activities and report all findings to Citoxlab | A Charles River Company (Citoxlab) management. Inform Citoxlab management of deficiencies and areas of operations that need improvement.

MAJOR ELEMENTS OF RESPONSIBILITIES

  • Perform critical phase, process and facility audits;
  • Perform thorough audits in compliance with applicable Standard Operating Procedures (SOPs), study plans, Good Laboratory Practice (GLP) regulations and guidance documents;
  • Communicate and report audit findings in a timely manner to the responsible personnel;
  • Work closely with scientific staff and Operations to achieve GLP compliance;
  • Ensure GLP regulations and guidance, as well as Citoxlab SOPs are followed;
  • Understand and consistently apply SOPs;
  • Maintain good verbal and written communication with Operations;
  • Inform QA management of deficiencies and suggest improvement;
  • Meet and adhere to set deadlines;
  • Remain informed on all legislation and developments related to job through self-education and external training;
  • Assist in training of staff;
  • Substitute and/or assist department colleagues;
  • Perform any other reasonable tasks that may be required.
WORKING ENVIRONMENT

  • Work performed in an office environment;
  • Considerable sensory attention is required on a regular basis;
  • Often requires concentration to work in front of a computer;
  • Work with deadlines.
KNOWLEDGE/SKILLS

  • University degree or pertinent experience in the domain;
  • Minimum of 1 year of experience as Quality Assurance Auditor in a GLP regulated environment or equivalent;
  • Strong knowledge of related legislation, principles, practices and procedures;
  • Good knowledge and application of GLP;
  • Oral and written English required. French is a definite asset;
  • Strong organizational, interpersonal and communication skills;
  • Strong problem-solving and analytical skills;
  • Ability to work under time constraints and adapt to change;
  • Meticulous attention to detail;
  • Good practical knowledge of auditing computerized systems validation for compliance is a definite asset;
  • Working knowledge of related computer applications; Fast typing ability is an asset.