Quality Assurance Specialist - Pharmaceutical/Biopharmaceutical

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

EMD Serono in Mississauga, Ontario is seeking a Quality Assurance Specialist.  In this role, you will support the Quality Department in executing Quality and Compliance activities in accordance with GMP and GDP requirements, including Drug Products/Medical Device guidelines.  You will assist in implementing the defined Global Healthcare Operations strategy while ensuring the effective deployment and continuous improvement of our Quality Management System.

Responsibilities:

Manage products releases, complaints process, including deviations, investigations and documentation via Falcon (Quality Management System); maintaining meticulous records of customer complaints and providing required complaint responses

Adhere to Change Control and Deviation procedures and manage data entry into Falcon (Quality Management System)

Compile, track, and share trend reports while collaborating with stakeholders to propose appropriate corrective and preventive actions (CAPAs)

Assist with the creation and periodic review of Standard Operating Procedures and Work Instructions to ensure they remain aligned with our Healthcare Quality requirements and are readily accessible through our documentation management system (Mango)

Verify product releases at subsidiaries to confirm compliance, assessing product returns to determine suitability for resale or destruction, and participating in our Right First-Time initiative to enhance local processes

This is a limited contract position based onsite in Mississauga, with a contract length of 13 months.

Who You Are:

Minimum Qualifications:

Bachelor's degree in Pharmacy, Chemistry, or other Life Sciences field

1+ year of hands-on experience within the Quality Department

Preferred Qualifications:

Background in medicinal product distribution with at least three years of experience in Quality Assurance within the Pharmaceutical/Biopharmaceutical industry

Regulatory Affairs experience and knowledge of Good Manufacturing/Distribution Practices

Familiarity with Health Canada regulations/guidelines

Fluency in English

Highly organized with excellent time management skills and the ability to prioritize effectively in a dynamic, fast-paced environment

Strong analytical and problem-solving abilities with a demonstrated proactive mindset

Excellent communication skills and ability to work collaboratively within team environments and with cross-functional partners

Willingness and enthusiasm to learn new skills

This is an existing vacancy.

Pay Range for this position: $68,400 - $83,600

Our ranges incorporate all levels and career types available within this specific role and are derived from relevant industry market data within Canada. Should we decide to make an offer, we will consider several factors, including but not limited to your skills, experience, career level, and other job-related factors. This role may offer the following benefits: health, vision, and dental coverage; life insurance; disability; a Defined Contribution Pension Plan program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses. We use AI in the process of screening, assessing and/or selecting applicants. Further details on how we use AI in our recruitment process can be found  here .

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!