QC Reviewer, Sample Management

Primary Responsibilities

The QC Reviewer I, Sample Management, is responsible for sample management general activities:

• Performs the quality control review of the documentation related to the Sample Management team.

• Performs audits within the team to ensure that quality standards are respected

Tasks Performed

The QC Reviewer I, Sample Management, is responsible for

• Performs 100% QC review on documentation generated by the Sample Management Department for one specific group and follow-up with technical staff.

• Conducts all work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies.

• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues.

• Archiving documentation.

• Suggests solutions and improvements.

• Performs any other duties as required by management.

The QC Reviewer I, for Reception group is responsible for

• Performs confirmation of sample reception.

• Generates and communicates data logger results.

• Updates of Kanbanize cards.

• Enters discrepancies in tracker.

• Performs QC review of documentation and information recorded in Watson LIMS.

The QC Reviewer I, for Service group is responsible for

• Performs QC review of all forms completed within Service group.

• Performs QC review of CR transactions in Freezer Pro and Watson LIMS.

• Performs QC review of Matrices transactions in Freezer Pro.

• Performs QC review of study material transactions in Watson LIMS.

• Follow-up of corrections to be performed by Analysts and/or Technicians.

The QC Reviewer I, for Destruction/Shipment group is responsible for:

• Preparation of appropriate destruction/shipment forms for Technicians

• Communication with Scientist, Client Manager and Archiving team

• Creation and update of Kanbanize cards.

The QC Reviewer I, for Reference Standard group is responsible for:

• Handles and manages the reception, storage, inventory, request, dispensing, shipping and tracking of reference standards (RFS).

• Management of the reference standard recertification.

• Completes and generates RFS log sheet.

• Performs 100% QC review on documentation generated by the Reference Standard.

• Writes memo to files in support of raw data for supplementary information.

• Manages the disposal of Reference standards.

• Management of Material safety data Sheet

• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues.

• Certificate of analysis interpretation.

• Respond to QA citations pertaining to reference standards

• Performs archiving documentation

• Performs any other duties as required by management.

Communication

• Internal: Intradepartmental, Interdepartmental: IT, QA, BD, PM and Clinic.

• External: Sponsors and external clinics.

Qualifications

Educational

• Diploma of College Studies in Sciences or B.Sc.

Experience

• Experience in sample management in the medical or pharmaceutical industry

• At least 1 year of experience in Quality Control

• Knowledge of FDA-GLP/GCP and GDP

Skills

• Good organizational skills and interpersonal skills

• Attentive to details.

• Customer-focused.

• Good communication in both French and English

• Works well within a team

• Proficient in Excel, PowerPoint, Word.

• Knowledge of SharePoint Office 365 would be an asset

• Knowledge of Watson LIMS would be an asset

• Ability to work in a fast-paced environment

• Ability to multi-task with attention to details