QC Reviewer, Sample Management (12-month contract)

Altasciences Company; Laval; On-site; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Training and development programs

Employee orientation bonus program

Annual performance reviews

Job summary

Altasciences is seeking a QC Reviewer in the Sample Management Department to perform quality control reviews of documentation and conduct internal audits to ensure regulatory compliance. The role includes drafting and revising SOPs for sample management and glass washing, as well as updating training materials.

The candidate should have a health sciences background with at least 3 years of experience, strong knowledge of FDA-GLP, GCP and TPD regulations, and be fluent in French and English.

Qualifications

• 3+ years of experience in health sciences or related field.
• In-depth knowledge of FDA-GLP, GCP and TPD regulations.
• Experience in medical/pharma field is an asset.
• Strong GLP/GCP focus and attention to detail.
• Bilingual in French and English.

Responsibilities

• Perform 100% quality control on documentation generated by the sample management team.
• Conduct audits within the team and write reports.
• Draft/revise SOPs for sample management and glass washing.
• Maintain and archive documentation and train materials.

Skills

Management

Organizational skills

Communication

Leadership

Decision making

Problem solving

Customer oriented

Bilingual French/English

Education

Health sciences degree or higher

Tools

Access

Outlook

MS-Office

Watson

Job description

About the role

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.

What you'll be doing here

• 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.

What you need to succeed

• You 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 offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

• Training and development programs
• Employee orientation bonus program
• Annual performance reviews

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