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Specialist, Reference Standard

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

AI generated summary

  • You need a B.Sc. in chemistry or related field, 1+ year of experience with reference standards, bilingual (French/English), and proficiency in MS Office. Knowledge of regulations is essential.
  • You will manage RFS activities including inventory, storage, and shipping of controlled substances, ensure regulatory compliance, assist in inspections, and improve operational efficiency.

Requirements

  • B.Sc. Degree from a recognized Canadian University for which the main area of study consisted of chemistry, biochemistry, pharmacology or equivalent degree
  • At least 1 year of experience with characterization of reference standards.
  • Proficient in the ability to interpret certificates of analysis. Knowledge of Cannabis and Controlled substances regulations and Act. Knowledge of USP, BP pharmacopeia and ICH guidelines.
  • Knowledge of the transportation of dangerous goods regulations is an asset
  • Excellent written/oral communication skills.
  • Must be bilingual (French and English).
  • Customer-focused. Software: Access, Outlook, MS-Office

Responsibilities

  • Oversee and participate of day to day of RFS activities, including the receipt, inventory, storage, dispensation and shipping of RFS
  • Responsible of managing the Cannabis and Controlled substances (order, receipt, dispensation, inventory, storage, shipping)
  • Responsible for all reports management of Cannabis and Controlled substances with Health Canada
  • Assist the supervisor during sponsors and agencies inspections
  • Ensure adherence to Cannabis and Controlled substances regulations and Act
  • To Act as the Alternate Qualified Person in Charge (AQPIC) for controlled substances and Cannabis products. Knowledge and follow Cannabis and Controlled substances regulations, Act and Guides
  • Assist on the preparing and submitting reports and licence applications to health Canada
  • To provide assistance for improving efficiency and output of RFS management operations
  • Assists the supervisor in the quotation request, order, training, writing of internal documentation, QA citations
  • To review and/or approve documentation regarding RFS activities in accordance with operating procedures, GLP/GCP and health Canada regulations
  • Ensure that all RFS are received and characterized in accordance with internal procedures
  • To conduct all work in compliance with SOPs, GLPs, GCPs and observe all company guidelines and policies

FAQs

What is the primary responsibility of the Specialist, Reference Standard?

The primary responsibility is to oversee and participate in the operational activities of the Reference Standard (RFS) team, including the management of cannabis and controlled substances.

What qualifications are required for this position?

A B.Sc. Degree from a recognized Canadian University in a field such as chemistry, biochemistry, pharmacology, or an equivalent degree is required, along with at least 1 year of experience with characterization of reference standards.

Is bilingualism a requirement for this role?

Yes, the position requires proficiency in both French and English.

What kind of experience is preferred for candidates applying for the Specialist, Reference Standard position?

Candidates should have at least 1 year of experience with characterization of reference standards and proficiency in interpreting certificates of analysis.

What types of regulations will I need to be familiar with in this role?

You will need to have knowledge of cannabis and controlled substances regulations, the Cannabis Act, USP, BP pharmacopeia, ICH guidelines, and transportation of dangerous goods regulations is an asset.

What software skills are necessary for this job?

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

What benefits does Altasciences offer to employees?

Altasciences offers a comprehensive benefits package that includes health/dental/vision insurance, a 401(k)/RRSP plan with employer match, paid vacation and holidays, paid sick and bereavement leave, and employee assistance programs.

Are there opportunities for professional development at Altasciences?

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

Will I be involved in regulatory inspections?

Yes, the Specialist will assist the supervisor during sponsors and agencies inspections as part of their role.

What is the company’s stance on diversity and inclusion?

Altasciences is an equal opportunity employer committed to diversity and inclusion, aiming to attract and retain highly talented employees from diverse backgrounds.

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.