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QC Reviewer, Sample Management (12-month contract)

  • Laval, QC, Canada

Full-time

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Job details

Job type
Full-time
Experience
You have a high school diploma or higher in health sciences or equivalent with at least 3 years' experience.
Posting language
English
Posted

Original 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.


Altasciences' incentive programs include:

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

More about this job

Responsibilities

The QC Reviewer is responsible for performing quality control on documentation generated by the sample management team and conducting internal audits. They also draft and revise standard operating procedures and training materials to ensure compliance with regulatory standards.

Requirements

Candidates must have a high school diploma or higher in health sciences with at least 3 years of relevant experience. In-depth knowledge of FDA-GLP, GCP, and TPD regulations is required, along with bilingual proficiency in English and French.

Skills

  • Quality control
  • Auditing
  • Standard operating procedures
  • Regulatory compliance
  • GLP
  • GCP
  • Documentation management
  • Leadership
  • Decision-making
  • Problem-solving
  • Communication
  • Organizational skills
  • Access
  • Outlook
  • MS-Office
  • Watson

Benefits

  • Training and development programs
  • Annual performance reviews

Visa sponsorship

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Categories

  • Science & Research
  • Healthcare
  • Administrative

Keywords

  • Quality Control
  • Sample Management
  • Auditing
  • SOP
  • GLP
  • GCP
  • TPD
  • FDA
  • Pharmaceutical
  • Clinical Research
  • Documentation
  • Regulatory Affairs
  • Access
  • Outlook
  • MS-Office
  • Watson
  • Health Sciences
  • Compliance
  • Training
  • Reporting

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