Career Category

Job Description

Title: Specialist, QA

Reports to: Sr Manager, QA

Function: International Distribution Quality (IDQ)

Location: Mississauga Head Office

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: 

• Provide leadership and guidance to the IDQ Canada team
• Represent IDQ Canada as a Subject Matter Expert (SME) during internal/external audits and inspections 
• Gather KPI metrics data and present at quarterly Amgen Canada and regional Management Review (MR) meetings
• Primary contact for external-facing interactions with local 3rd party GMP service providers and customers
• Manage activities with local 3rd party GMP service providers for qualification, change controls, deviations, CAPA, KPI metrics and complete annual Periodic Monitoring Reports
• Negotiate Quality Agreements (QAGRs)
• Attend Amgen CQC audits of local GMP service providers and track any CAPAs to closure
• Manage the Executed Batch Record (EBR) review program
• Manage the Annual Full Confirmatory Testing program
• Execute QA milestones for local product launches
• Review SOPs, APRs, YBPRs and stability data
• Provide market reportability assessments for deviations and complaints
• Act as a backup for the Sr QA Associate
• Act as a delegate for the Sr QA Manager
• Perform other tasks and projects as assigned  

Basic Qualifications

BSc degree

Preferred Qualifications

• 5+ years of Pharmaceutical Industry experience, ideally in a QA leadership role
• Bachelor’s Degree in the Physical or Biological Sciences
• Strong understanding of the Pharmaceutical and Biotechnology Industries
• Expert working knowledge of the Health Canada GMP/GDP Regulations
• Strong leadership skills
• Superior communication and interpersonal skills
• Ability to prioritize multiple responsibilities in a dynamic work environment 
• Strong problem-solving skills
• Strong, independent decision-maker that can balance business needs with quality and compliance risk
• Strong time management skills
• Process improvement mindset 
• Experience managing 3rd party GMP service providers (e.g. LSPs, Contract Labs)
• Experience using SAP, Trackwise, and Quality Management Systems (QMS)  
• Experience using Microsoft Office software (Word, Excel, PowerPoint, Teams)

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.