Sr. Quality Assurance Associate - Canada (1yr contract)

Astellas; Markham; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking pharmaceutical company as a Quality Assurance Associate, where you'll play a pivotal role in ensuring compliance with Good Distribution Practice Guidelines. This hybrid position offers the opportunity to work both in-office and remotely, enabling you to contribute to quality assurance activities that directly impact patient safety. You'll be part of a collaborative culture that values innovation and accountability, working alongside talented professionals dedicated to making a difference in healthcare. If you're passionate about quality and eager to thrive in an empowering environment, this role is perfect for you.

Qualifications

• Experience in quality assurance activities within a pharmaceutical setting.
• Knowledge of Good Distribution Practice Guidelines and Quality Management Systems.

Responsibilities

• Perform standard quality assurance activities governed by GDP Guidelines.
• Support inspection management and represent Affiliate QA in project teams.

Skills

Good Distribution Practice Guidelines (GDP)

Quality Assurance processes

Nonconformance management

Supplier management

Education

Bachelor's degree in Life Sciences

Quality Assurance certification

Job description

Sr. Quality Assurance Associate

Astellas Canada – People Operations Partner

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant, and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria, and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet exciting opportunities with our legacy brands and pipeline of innovative treatments.

We seek candidates who thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way—patient focus, ownership, results, openness, and integrity? Then we would love to hear from you.

From day one, everyone at Astellas has a responsibility to create a brighter future for patients worldwide. We nurture relationships that allow our employees to thrive, foster innovation, and deliver exceptional results. We aim to create a culture where our people feel empowered to pursue bold ideas and ambitious outcomes, confident in their accountability and embodying a solutions-oriented mindset.

Our expertise, science, and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Astellas Pharma Canada (APCA) is currently searching for a Quality Assurance Associate reporting to the Head of Quality Assurance, Established Mid-Sized Markets Canada.

Description:

The role involves independently completing standard quality assurance activities within the affiliate. The position supports the Responsible Person, where applicable, and the QA Lead to fulfill their responsibilities and accountabilities.

• This is a 1-year fixed-term contractual position.

Essential Job Duties:

• Performs, records, and processes all standard, non-complex activities governed by Good Distribution Practice Guidelines (GDP Guidelines) as defined in the global Quality Management System. This includes QA oversight of product storage and distribution, nonconformance management, product complaint handling, change control, supplier management, and annual product review. Implements improvements to address inefficiencies and non-conformances.
• Supports inspection management for the wholesale dealer license (or equivalent), particularly during inspections and recalls.
• Represents Affiliate QA in recurrent, non-complex local and global project teams, such as workflow training and onboarding training.
• Performs QA acceptance and/or triage, but not final acceptance, of all QA records (except for product returns).
• Acts as a role model for the Quality Culture within the affiliate.

This position will be hybrid, with 50% in-office work and 50% remote work.

ReqID: 24-POS00070720M