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QC Reviewer, Sample Management (12 month contract)

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Altasciences

Sep 13, 2024

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

AI generated summary

  • You need a high school or higher degree in health sciences, 3 years' experience, knowledge of FDA-GLP, GCP, TPD, bilingual in French/English, with strong communication, leadership, and detail orientation.
  • You will conduct quality control reviews, audits, document deviations, respond to QA citations, manage SOPs, and ensure compliance with regulations and company policies.

Requirements

  • High school degree/or higher degree in health sciences or equivalent with at least 3 years of experience.
  • Must possess an in-depth knowledge of FDA-GLP, GCP and TPD regulations.
  • Experience in the medical or pharmaceutical field is an asset.
  • Excellent management, organizational, communication (both written and verbal) and interpersonal skills.
  • Strongly GLP/GCP-minded.
  • Attentive to details.
  • Strong leadership, decision making and problem solving ability.
  • Customer-focused.
  • Must be bilingual (French and English).
  • Software: Access, Outlook, MS-Office, Watson.

Responsibilities

  • Performs 100% quality control review on documentation generated by the Sample Management team.
  • In charge of the quality within the Sample Management team.
  • Performs audits within the team: develops, executes and reports.
  • Fills out supplementary information forms as needed to ensure documentation is accurate and complete.
  • Completes documentation as required to track deviations and reports of non-compliance within the team.
  • To respond to QA citations.
  • Performs documentation archiving.
  • To write, revise and/or review SOPs pertaining to sample management and glass washing.
  • To write, review and/or update training documents.
  • To keep up to date with respect to pertinent regulatory developments in the industry.
  • To conduct all work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies.
  • Stay up to date on new SOPs, procedures, and techniques via training sessions, meetings and internal communication avenues.

FAQs

What is the duration of the contract for the QC Reviewer, Sample Management position?

The contract is for 12 months.

What are the working hours for this position?

The position requires 37.5 hours of work per week.

Where is the job located?

The position is onsite at our Laval site located at 575 Boul. Armand Frappier.

Is this position accessible by public transportation?

Yes, the location is accessible by public transportation, specifically the Metro Montmorency, and there is free parking available for employees.

What qualifications are required for this role?

A high school degree or higher in health sciences or an equivalent field with at least 3 years of experience is required.

Is knowledge of regulations like FDA-GLP and GCP necessary?

Yes, an in-depth knowledge of FDA-GLP, GCP, and TPD regulations is a requirement for this role.

What skills are emphasized for this position?

Strong management, organizational, communication, interpersonal skills, attention to detail, leadership, decision-making, and problem-solving abilities are emphasized.

Are fluency in French and English required for the role?

Yes, candidates must be bilingual in French and English.

What software skills are needed for the position?

Proficiency in software such as Access, Outlook, MS-Office, and Watson is required.

Does Altasciences offer any employee benefits?

Yes, Altasciences offers a variety of benefits including training and development programs, an Employee Referral Bonus Program, and annual performance reviews.

How does Altasciences approach diversity and inclusion?

Altasciences is committed to diversity and inclusion, aiming to attract, develop, and retain talented employees from diverse backgrounds and ensuring equal consideration for all qualified applicants.

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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.