Job Description

Career Category Quality

HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Sr. Associate, Quality Assurance (1 Year Contract)
Reports to: Sr Manager, Quality Assurance
Location: Flexible Commuter (Hybrid) based out of our Mississauga office
Live
What you will do
Let’s do this. Let’s change the world! In this vital role you will review batch documentation for commercial and clinical products and perform product disposition as per Standard Operating Procedures (SOPs).
Responsibilities:

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  Write SOPs, protocols, technical reports, and memos in support of Quality activities
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  Participate as QA Owner/QA Contact for Non-Conformances (NCs), Corrective/Preventive Actions (CAPAs), Complaints, and Temperature Excursions
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  Review Annual Product Quality Reviews (APQRs) for commercial products
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  Schedule, compile, review, and coordinate filing of Yearly Biologic Product Reports (YBPRs)
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  Review Stability Summary Reports
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  Review executed batch records
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  Participate in and support/track follow-up actions from regulatory inspections by Health Canada and Amgen audits of local service providers (for Logistics, Testing)
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  Run stability data reports, assess data, and issue memos in support of temperature excursions impacting Amgen products
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  Develop and deliver GMP training
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  Ensure compliance with Canadian Food and Drugs Act and current Good Manufacturing Practice (GMP) regulations
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  Ensure compliance with Good Distribution Practice (GDP) regulations
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  Liaise with other divisions within the Canadian office, U.S. Head Office, and other international affiliates to exchange information to meet objectives
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  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 detail oriented professional we seek is organized and has these qualifications.
Basic Qualifications:
BSc degree
Preferred Qualifications:

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  3+ years of Pharmaceutical Industry experience in a Quality Assurance role
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  Bachelor’s Degree in the Physical or Biological Sciences
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  Strong understanding of the Pharmaceutical and Biotechnology Industries
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  Understanding of Health Canada GMP Regulations, specifically as they relate to drug product importation
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  Understanding of Health Canada GDP Regulations
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  Prior product disposition experience
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  Prior experience reviewing executed batch records
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  Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risk
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  Strong organizational skills and an ability to manage multiple tasks and responsibilities in a dynamic work environment
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  Ability to follow assignments through to completion and meet timelines
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  Excellent communication and interpersonal skills
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  Strong attention to detail and critical-thinking
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  Prior experience using SAP and Quality Management System (QMS) applications
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  Advanced experience using Microsoft Office software (Word, Excel, PowerPoint)

Thrive
Some of the vast rewards of working here
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.

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  Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
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  A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table

Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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