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QC Reviewer, Sample Management

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Altasciences

Oct 19

  • Job
    Full-time
    Mid Level
  • Laval
  • Quick Apply

AI generated summary

  • You need a high school diploma, 3 years' experience, knowledge of FDA-GLP, GCP, TPD regulations, bilingual in French and English, strong organizational and interpersonal skills, and proficiency in MS-Office.
  • You will ensure quality control of documentation, conduct audits, manage deviations, write SOPs and training materials, respond to QA citations, and stay updated on industry regulations.

Requirements

  • 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.

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.

FAQs

What is the main responsibility of the QC Reviewer in the Sample Management Department?

The main responsibility of the QC Reviewer is to perform quality control reviews of documentation related to the Sample Management team, conduct audits, and ensure adherence to quality standards.

What qualifications are needed for this position?

A high school diploma or higher in health sciences or equivalent, along with at least 3 years of experience, is required for this position.

Is bilingualism required for this role?

Yes, candidates must be bilingual in French and English.

What type of experience is considered an asset for this position?

Experience in the medical or pharmaceutical field is considered an asset for this position.

What software skills are necessary for the QC Reviewer?

Proficiency in Access, Outlook, MS-Office, and Watson is necessary for this role.

What is the work schedule for this position?

The position requires a commitment of 37.5 hours per week.

Where is the position located?

The position is on-site at Altasciences' Laval site located at 575 Boul. Armand Frappier.

Is there public transportation available for this location?

Yes, the site is accessible by public transit, specifically through the Métro Montmorency.

What kind of benefits does Altasciences offer?

Altasciences offers a comprehensive benefits package including Health/Dental/Vision Insurance, RRSP with Employer Match, Paid Vacation and Holidays, Sick Leave, and Employee Assistance Programs.

Are there opportunities for professional development in this role?

Yes, Altasciences provides training and development programs, as well as annual performance reviews to support employee growth.

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Altasciences

Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.

Science & Healthcare
Industry
1001-5000
Employees
1992
Founded Year

Mission & Purpose

Outsourcing made easy with a one-stop solution to early phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!

Culture & Values

  • Respect

    We are open to differences of opinions and value different viewpoints. We treat each other, our customers, participants in our studies, and the research animals in our care with dignity.

  • Quality and Excellence

    We provide services and solutions of the highest quality, and pride ourselves on challenging the status quo. We strive to exceed expectations by truly giving our best at everything we do.

  • Integrity

    We are honest and uphold strong moral principles. We conduct our business with transparency and high ethical standards.

  • Customer Focus

    We actively partner with our clients. We listen, remain accessible, deliver on commitments, and maintain open channels of communication to build and nurture a lasting relationship based on trust.

  • Employee Development

    We provide leadership, encourage professional development, recognize individual and team contributions, and offer a stimulating, safe working environment.