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For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

Drive Quality Forward: Your Expertise in Document Control & Training Awaits!

The QMS (Quality Management System) Document Control & Training Specialist is responsible for administrating the functionality of the Document Control & Training modules within the eQMS with departments globally in addition to supporting the improvements to the Document Control and Training processes to ensure a level of consistency and standardization in QMS.

This position is part of the Quality & Regulatory Department and will be located on-site in Concord, Ontario, Canada.

In this role, you will have the opportunity to:

Document Control & Training Administration: Oversee and manage the functionality of the Document Control and Training modules within the eQMS globally, performing daily electronic document changes (via Document Change Requests) in the eQMS, document reviews, document changes to ensure they are compliant to internal procedures and are being reviewed/approved by all appropriate functions and maintain archived records.

Training Management and Reporting: Assign required training to associates, prepare reports for departmental use, daily visual management, and audits, and ensure timely completion of training tasks while assisting in the development and delivery of training content.

Process Improvement and Standardization: Proactively improve Document Control and Training processes, support projects for consistency and standardization in QMS, troubleshoot issues, and enhance work instructions and procedures.

Guidance and Quality Culture Promotion: Provide guidance to team members on Document Control and Training processes, foster a quality culture through ongoing education and consultation in Quality/Regulatory requirements, and conduct training for process changes.

Monitoring and Audit Participation: SME (Subject Matter Expert) to Doc Control & Training during internal/external audits, monitor metrics on the efficacy and efficiency of Document Control and Training processes, provide regular status updates to the team and management, and participate in internal and external audits. Other duties as assigned.

The essential requirements of the job include:

• Educational Requirement: Bachelor’s degree in a science discipline or related field.

• Quality Assurance Experience: At least 4 years of experience in a quality assurance role, with GMP experience in biotechnology, pharmaceuticals, or medical devices preferred.

• QMS Standards Knowledge: Strong understanding of QMS standards such as ISO9001, ISO13485, and FDA 21 CFR Part 820.

• eQMS and Document Management: Required experience with electronic Quality Management Systems (eQMS) and electronic document management systems, as well as record management.

• Training and Procedure Writing: Experience in providing live/virtual training with good presentation skills and writing procedures that meet QMS requirements.

• Travel, Motor Vehicle Record & Physical/Environment Requirements:

• N/A

It would be a plus if you also possess previous experience in:

• Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.

• Ability to perform a variety of duties, often changing from one task to another to prioritize and comply with timelines.

• Able to work independently and problem solve

• Team Player: Thrives in a team environment to achieve a shared goal or outcome

SCIEX, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.