Quality Assurance Associate - Canada (1yr contract)

Astellas Pharma • Markham, IL

323d • Remote

About The Position

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. Astellas Pharma Canada (APCA) is currently searching for a Quality Assurance Associate reporting to Head, Quality Assurance, Established Mid-Sized Markets Canada. This is a 1yr fixed-term contractual position.

Requirements

• Degree in a science/health-related subject.
• 5+ years' relevant experience in a comparable role in the pharmaceutical industry preferred.
• Experience of implementation and understanding of GDP, GMP and Quality Management Systems preferred.
• Fluency in written and spoken English.
• Good organizational, coordination, presentation and communications skills.

Nice To Haves

• Experience with Trackwise (Digital), Veeva and SAP systems.
• Experience with handling regulatory interfaces such as inspections and audits.

Responsibilities

• Independently completes standard quality assurance activities in the affiliate.
• Supports the Responsible Person and the QA Lead to meet Responsibilities and Accountabilities.
• Performs, records and processes all standard, non-complex activities governed by Good Distribution Practice Guidelines (GDP Guidelines).
• Implements improvements to correct inefficiencies and non-conformances.
• Supports with inspection management for the wholesale dealer license during inspections and recalls.
• Represents Affiliate QA in recurrent, non-complex local and global project teams.
• Performs QA acceptance and/or triage of all QA records (apart from product returns).
• Acts as a role model for the Quality Culture in the affiliate.

Benefits

• Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.
• Recognition of the importance of work/life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree