Senior Associate, Quality Assurance

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

What you will do

Lets do this. Lets 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

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek is a strong communicator with these qualifications.

Basic Qualifications:

BSc degree

Preferred Qualifications:

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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

Amgen is proud to have been recognized as one of LinkedIn Top 25 Companies in Canada for career growth. Click HERE for more details.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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.