QC Reviewer, Sample Management (12-month contract)

Altasciences; Laval; On-site; CAD 60,000 - 90,000; Full time

Job summary

Altasciences in Laval, Canada is seeking a Quality Control Reviewer for the Sample Management Department. You will perform 100% QC on team documentation and contribute to audits and SOPs to ensure compliance with GLP, GCP, and FDA standards.

The role requires a health sciences background with at least 3 years of experience, strong organizational and communication skills, and bilingual French/English abilities.

Qualifications

• 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.
• Experience in the medical or pharmaceutical field is an asset.
• 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).

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 update training materials.
• Keep abreast of relevant regulatory developments in the industry.
• Keep abreast of new SOPs, procedures and techniques through training sessions, meetings and internal communications.

Skills

FDA-GLP knowledge

GCP knowledge

TPD regulations knowledge

Leadership

Communication skills

Bilingual French/English

Education

High school diploma or higher in health sciences

Tools

Access

Outlook

MS-Office

Watson

Job description

About the roleThe 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.What you'll be doing herePerform 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.What you need to succeedYou have a high school diploma or higher in health sciences or equivalent with at least 3 years' experience.You must have in-depth knowledge of FDA-GLP, GCP and TPD regulations.Experience in the medical or pharmaceutical field is an asset.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.Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of QC Reviewer, Sample Management including, but not limited to, for the following reasons:The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.What we offerAltasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.Altasciences' incentive programs include:Training and development programsEmployee orientation bonus programAnnual performance reviews#LI-MB1