safety assessment 

Quality Assurance Inspector

Canada - QC - Montréal

Charles River is looking for a Quality Assurance Inspector. The QA Inspector will be responsible for reporting study-specific audits in both process procedures and report texts. The QA Inspector will know Good Laboratory Practice regulation guidelines and Standard Operating Procedures as they apply to regulated research. The QA Inspector will also advise management of QA trends and assist in facility audits, system analyses, and training. 

Principal Investigator I

Tacoma, WA

The Principal Investigator I is responsible for advising sponsor organizations in the practical aspects of protocol; understanding study background, objectives, design, and criteria and having a full understanding of the investigational drug; overseeing clinical conduct of all studies; supervising the daily assessment of participants’ well-being; participating in and managing all phases of adverse events and related reporting; and participating in the writing and development of the final clinical summary.

Sr. Quality Assurance Auditor

Frederick, MD

The Senior QA Auditor performs audits of protocols, in-life critical phases, raw data, and final reports to assure accuracy and compliance with GLP regulations and SOPs and maintains written and signed records of auditing activities. Additional responsibilities include: preparing the Quality Assurance Statement to be included with audited final report; performing audits of the site’s Quality Systems, including corresponding regulatory documentation; assisting with site “FDA Readiness” assessments; performing qualification audit of subcontractors; assisting with sponsor/agency site audits; and providing company-wide GLP training sessions.

Global Loss Control Specialist, Finance

Wilmington, MA

The Global Loss Control Specialist is responsible for managing the corporate insurance loss control carrier relationship; developing loss control activities globally; advising company operations on recommendations for compliance and establishing Management by Objective (MBO) timeline; assisting the Risk Manager in establishing loss control benchmarking; evaluating existing policies and SOPs for loss control improvement and working with operations to develop new policies and procedures where needed; performing periodic vendor performance evaluations; implementing training for operations management on property and casualty issues related to loss control; participating in development of Charles River’s Business Interruption planning; and evaluating loss statistical data.