Job Description

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

How will you make an impact and, what will you do?
This position is required to provide comprehensive technical support and quality assurance oversight to maintain site compliance with GMP standards. Support functions which include, but are not limited to, documentation review, supplier management, process monitoring, change control, client relations and APQR Quality System. This role will interface closely with other cross-functional groups such as Operations, Maintenance, Engineering, R&D, Business Management and Quality.
Essential Functions:
2022 Participate on cross functional project team to provide open communication to clients on quality related issues and site standards associated with their project.
2022 Manage multiple clients, developing trust and confidence though their product2019s lifecycle.
2022 Partner with site (Logistics and Quality Assurance) and network resources to provide oversight of supplier management and site-specific supplier quality issues.
2022 Responsible for ensuring that all APQR2019s (Roche) are properly generated, reviewed and submitted.
2022 Lead and/or support through investigations of project-related quality issues (CAPA2019s, Discrepancies, Audit Observations, protocols, etc.), ensuring effective corrective and/or preventive actions occur.
2022 Provide regular status updates on client2019s quality expectations to local Quality assurance team.
2022 Interface with clients by assisting with addressing their questions and concerns as they relate to site strategy for controlling product quality through quality systems.
2022 Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects to enhance client satisfaction.
2022 Collaborate on and author supplier quality procedures.
2022 Review and approve change requests.
2022 Provide guidance to internal and external customers on best practices for maintaining a supplier quality program (including self-audit and supplier quality).
2022 Participate in audits and inspections performed by clients.
2022 Participate in inspections by regulatory agencies, as needed.
2022 Perform other duties as required.
Supervision: This position does not have supervisory responsibilities, but may include oversight of project teams.

How will you get there?
Education: Bachelor2019s Degree in Engineering or related discipline
Experience:
2022 3-5 years2019 experience in the pharmaceutical, biopharmaceutical or related industry, with sound knowledge and experience of GMP (or equivalent regulations). An equivalent mix of education and experience is acceptable
2022 Knowledge of 21 CFR 110, 21 CFR 211, ICH Q7 and other regulatory standards governing the manufacture of bulk drug substances preferred.
2022 Previous project management experience is a plus
2022 Experience managing external customers is a plus
2022 Direct manufacturing experience is a plus
2022 Tech transfer experience is a plus

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.