Lab Investigator
Thermo Fisher Scientific
Whitby, ON
Job Description
How will you make an impact?

With 70000 extraordinary minds on our global team, each one of us at Thermo Fisher has an important story to tell. Whether we’re helping customers to fight disease, making sure our air is clean, or solving cold cases, our stories involve thousands of important projects that improve millions of lives. Our dedicated sales professionals are laser focused on delivering our customer value proposition—accelerating innovation and enhancing productivity. With talented managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world.

What you will do?

In this critical role you will initiate and lead quality investigations including Out of Specification (OOS) and unexpected results investigations and deviations.

We have two positions at our Whitby site.

Essential Functions:
Initiates and leads investigations and authors investigation reports in TrackWise.
Provides technical leadership on investigations.
Conducts investigations with input from stability and/or development supervisor.
Directs Research Chemists in the performance of lab investigations.
Interacts with other departments (e.g., Pharmaceutics and Process Technology, Project Management, QA), clients and with Subject Matter Experts (SMEs), as required, to thoroughly investigate incidents, conclusions, and appropriate Corrective Action Preventative Actions (CAPA).
Ensures that investigations are ready for approval and completed within required time frames.
Provides excellence in data integrity and GMP/procedural compliance.
Designs and facilitates effective CAPA actions.
Owns CAPA actions as needed.
Challenges the department on quality issues and system improvements.
Other related duties as assigned.
How will you get there?

Requirements:
Bachelor's degree in Chemistry.
Minimum 5 years analytical chemistry experience within the pharmaceutical industry.
Experience with Empower and TrackWise.
Previous experience in providing client service in the contract pharmaceutical industry.
Previous method validation and product stability testing/reporting experience in the pharmaceutical industry.
Previous investigations experience in an analytical laboratory environment.
Exceptional knowledge of Good Manufacturing Practices, and United States Food and Drug Administration (FDA) compliance.
Strong interpersonal and communication skills (both oral and written).
Excellent organizational skills with proven ability to prioritize when timeline conflicts exist.
Ability to problem solve and troubleshoot.
Ability to carry out investigations in a collaborative manner with laboratory staff and to effectively interact with internal and external suppliers and clients.
Microsoft skills (Word, Excel, PowerPoint).
Proficiency with the English language.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.