QC Reviewer, Sample Management

CareAbout•Laval, QC

About The Position

The Quality Control Reviewer, Sample Management Department, is responsible for the quality control review of documentation related to the Sample Management team. He/she also conducts audits within the team to ensure that quality standards are met. He/she participates in the drafting and/or revision of standard operating procedures for sample management and glass washing.

Requirements

High school diploma or higher in health sciences or equivalent with at least 3 years' experience.
In-depth knowledge of FDA-GLP, GCP and TPD regulations.
Excellent management, organizational, communication (written and oral) and interpersonal skills.
Strong GLP/GCP focus.
Detail-oriented.
Strong leadership, decision-making and problem-solving skills.
Customer oriented.
Must be bilingual (French and English).
Software: Access, Outlook, MS-Office, Watson.

Nice To Haves

Experience in the medical or pharmaceutical field is an asset.

Responsibilities

Perform 100% quality control on documentation generated by the sample management team.
Responsible for quality within the sample management team.
Perform audits within the team: develop, execute and write reports.
Completes additional information forms as necessary to ensure documentation is accurate and complete.
Complete documentation necessary to track deviations and non-conformance reports within the team.
Respond to QA citations.
Archive documentation.
Write, revise and/or review standard operating procedures for sample management and glass washing.
Write, revise and/or update training materials.
Keep abreast of relevant regulatory developments in the industry.
Perform all work in accordance with applicable SOPs, GCPs and GLPs and adhere to all company guidelines and policies.
Keep abreast of new SOPs, procedures and techniques through training sessions, meetings and internal communications.