Amgen Sr. Associate Quality Assurance (1 Year Contract) in Mississauga, Ontario
Title: Sr Associate Quality Assurance (1 Year Contract)
Reports to: Sr Manager QA
Location: Mississauga Head Office
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 (https://www.amgen.ca/sciencedispatch/behind-the-scenes/)
Review batch documentation for commercial and clinical products and disposition 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 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
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 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.
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 .
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.