When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
The primary purpose of this position is to provide direct quality support to ensure compliance with regulations that govern pharmaceuticals. Full compliance ensures Patheon, part of Thermo Fisher Scientific, can operate without regulatory actions that impede product quality, cause product stoppages, or reduce customer satisfaction.
- Comply with all job-related safety and other training requirements. It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
- For processes and projects of low to moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements; ensure adherence to current regulations with little dependence on others.
- Provide leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.
- Perform document reviews and made determinations as to whether work performed meets current procedures and regulatory expectations. Communicate and coordinate with other departments as required to resolve issues and compliance concerns detected during review.
- Conduct risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
- Comply with all job-related safety and other training requirements.
- Other duties as assigned.
- BS in related field plus 2 years of relevant experience. OR MS in related field (Computer science, Chemistry, Biology, or physical/life science).
- Thorough knowledge of GMPs
- Multiple computer skills including working experience with MS Office applications such as Word and Excel and general experience in computer systems associated with quality assurance functions such as lot review, SOP review and approval, lab results reviews (LIMS), disposition of product and validation document reviews.
- 2-4 years’ experience in Pharmaceutical or regulated environment
- Experience in reviewing technical and scientific data associated with pharmaceuticals.
At Thermo Fisher Scientific, each one of our 65,000 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.