Career Category

Job Description

Title: Sr Associate Quality Assurance (QA)

Reports to: Sr Manager QA

Location: Mississauga

Req#: R-90348

JOB SUMMARY

Working at Amgen
At Amgen you’ll experience a work environment where employees strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health. Amgen provides the working environment you have always strived for - A perfect combination of science and entrepreneurship that brings therapies to market by people that have a true passion for their work.

Our culture is what makes Amgen a special place to work. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Take a few minutes to hear what some of our current staff members are sharing about working at Amgen. Click HERE

Responsibilities: 

• Review batch documentation for commercial and clinical products and perform product disposition as per Standard Operating Procedures (SOPs)
• Write SOPs, protocols, technical reports, and memos in support of Quality activities
• Participate as QA Owner/QA Contact for Non-Conformances (NCs), Corrective/Preventive Actions (CAPAs), Complaints, and Temperature Excursions
• Review Annual Product Quality Reviews (APQRs) for commercial products    
• Schedule, compile, review, and coordinate filing of Yearly Biologic Product Reports (YBPRs)  
• Review Stability Summary Reports
• Review executed batch records    
• Participate in and support of follow-up actions from regulatory inspections by Health Canada
• Participate in and tracking of follow-up actions from Amgen audits of local service providers (for Logistics, Testing)
• Run stability data reports, assess data, and issue memos in support of temperature excursions impacting Amgen products
• Develop and deliver GMP training
• Ensure compliance with Canadian Food and Drugs Act and current Good Manufacturing Practice (GMP) regulations
• Ensure compliance with 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

Basic Qualifications

BS 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)

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact TalentAcquisitionInquiries@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.