Document Specialist

Roche • Mississauga, ON

1d • CA$89,256 - CA$117,149 • Onsite

About The Position

At Roche, we foster a culture where individuals can express themselves authentically, embracing their unique qualities. Our environment encourages personal expression, open dialogue, and genuine connections, ensuring everyone feels valued, accepted, and respected. This allows for both personal and professional growth, as we collectively strive to prevent, stop, and cure diseases and ensure universal access to healthcare for current and future generations. Join Roche, where every voice matters. A healthier future is our driving force for innovation. We are committed to continuously advancing science and ensuring that everyone has access to the healthcare they need, today and for generations to come. Our mission is to create a world where we all have more time with the people we love. This is the essence of Roche. Quality is a significant competitive advantage for Roche, enabling us to deliver high-quality products to patients, maintain our right to operate, and create value through process excellence and continuous improvement. This philosophy is embedded throughout the Pharmaceutical Technical Operations organization, emphasizing that quality is both a patient's right and every employee's responsibility.

Requirements

• B.A., B.S. or higher degree (preferably in Life Science or a related field).
• 3 - 5 years of applicable cGMP pharmaceutical or biopharmaceutical (or related industry) experience.
• Strong knowledge of industry standards, including ALCOA+ principles, cGMP requirements, and ICH guidelines.
• Experience with Quality Systems, document management, and technical writing.
• Experience collaborating to support global teams and Quality initiatives.
• Ability to operate in a self-managed way of working, with a key focus on collaboration and a Quality mindset.
• Ability to work in a purpose-driven organization, taking full ownership for assigned roles and tasks.

Nice To Haves

• Experience in a Quality Control environment is a plus.

Responsibilities

• Ensure that data in documents, electronic systems, and regulatory filings meet Quality and GMP standards, contributing to Network QC’s operational success.
• Support the development, maintenance, and execution of Network QC projects and administrative activities.
• Perform compliance review of data, technical documents, and regulatory filings.
• Manage the lifecycle of records within the Electronic Document Management System (e.g., Veeva), including the timely completion of periodic reviews.
• Serve as a key liaison within Network QC to support documentation-related activities, including support for inspection and planned event management.
• Set personal performance goals and establish work priorities to meet goals and timelines for assignments.
• Demonstrate a strong focus on customer support and effectively manage stakeholder expectations.
• Support Network QC and Quality goals while ensuring deliverables are completed in a compliant, accurate, and timely manner.

Benefits

• Relocation benefits are not available for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level