Job Details

JOB DESCRIPTION

WHY IS THIS A GREAT OPPORTUNITY?

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 Montreal, QC CRO preclinical testing laboratory seeks a Senior GLP QA Auditor to monitor studies, systems, data, and procedures to make sure that work is done in compliance with GLP.

This person would have several years' experience, and be able to mentor more junior staff. The company is expanding rapidly and is an exciting and challenging place to be.

JOB DESCRIPTION

ROLE AND RESPONSIBILITIES:
- Audit toxicology study plans, reports, raw data re completeness, accuracy and GLP compliance.
- Investigate the critical phases of all preclinical studies re method validation, sample analysis for compliance with study plans,
to ensure compliance with SOPs, GLP.
- Attend an average of 4 necropsies procedures per month.
- Write  inspection reports, finalize reports and audit sub-contractors.
- Communicate non-compliance to study personnel, directors, and management and recommend  corrective action.
- Audit facility/laboratory as required.
- Make sure there are written and signed records of auditing activities.

QUALIFICATIONS

REQUIREMENTS:

B.Sc. or DEC with several years working in a GLP unit.
QA inspection/audit experience with respect to toxicology and related preclinical studies.
Must be willing to attend an average of 1 necropsy per week.
Excellent comprehension of Good Laboratory Regulations.
Able to train others.
Strong English and French communication skills.
Detail oriented with excellent interpersonal, organizational, or team player skills.

 

Education:
University - Associate's Degree/Graduate Diploma/2 Years