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