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Amgen Senior Associate, Quality Assurance (1 Year Contract) in Mississauga, Ontario

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Title: Sr Associate Quality Assurance (1 Year Contract)

Reports to: Senior Manager QA

Location: Mississauga Flexible Commuter

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will:

Responsibilities:

  • Review batch documentation for commercial and clinical products and disposition product as per Standard Operating Procedures (SOPs)

  • Participate as QA Owner/QA Contact for Deviations, Corrective/Preventive Actions (CAPAs), Complaints, and Temperature Excursions (TEs)

  • Review Annual Product Reviews (APRs) for commercial products

  • Schedule, compile, review, and coordinate filing of Yearly Biologic Product Reports (YBPRs) for commercial products

  • Review Stability Summary Reports

  • Review Executed Batch Records

  • Draft SOPs, Protocols, Technical Reports, and memos in support of Quality activities

  • Run stability data reports, assess data, and issue memos in support of TEs for Amgen products

  • Complete Quality launch achievements

  • Develop and deliver GMP training

  • Represent IDQ Canada from internal/external audits and inspections

  • Represent IDQ Canada at cross-functional meetings for complaints, disposition, and launch

  • Represent IDQ Canada as a Subject Matter Expert (SME) during internal/external audits and inspections

  • Ensure compliance with Canadian Food and Drugs Act, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP) regulations

  • Liaise with other divisions within the Canadian office, U.S. Head Office, and other international affiliates to exchange information to meet objectives

  • Perform other quality tasks and projects as assigned by Manager

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality Assurance professional we seek is someone with these qualifications.

Basic Qualifications:

Bachelors degree

Preferred Qualifications:

  • 3+ years of Pharmaceutical Industry experience in a Quality Assurance role

  • Bachelor’s Degree in the Physical or Biological Sciences

  • Strong understanding of the Pharmaceutical and Biotechnology Industries

  • Understanding of Health Canada GMP Regulations, specifically as they relate to drug product importation

  • Understanding of Health Canada GDP Regulations

  • Prior product disposition experience

  • Prior experience reviewing executed batch records

  • Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risk

  • Strong organizational skills and an ability to manage multiple tasks and responsibilities in a dynamic work environment

  • Ability to follow assignments through to completion and meet timelines

  • Excellent communication and interpersonal skills

  • Strong attention to detail and critical-thinking

  • Prior experience using SAP and Quality Management System (QMS) applications

  • Advanced experience using Microsoft Office software (Word, Excel, PowerPoint)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers the following to staff on contract:

  • An option of a comprehensive health benefits package, or an additional 10% “in lieu of benefits” allowance

  • Award-winning time-off plans and annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

  • Robust Learning and Development opportunities

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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