JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Role: Senior Associate QA
Reports to: Senior Manager QA
Location: Mississauga Flexible Commuter

BASIC QUALIFICATIONS:

BSc 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)

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

• 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 milestones
• 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