Senior QA Coordinator
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
Daily responsibilities include:
Review and approve production and quality control Batch Records. Perform batch release including: labeling, ERP transactions, document control, filing and other related tasks.
Perform quality tour of manufacturing area to ensure compliance and provide coaching for operators.
Manage training assignment and record control through paper form and SAP-LMS system, acts as lead in SAP training coordination.
Work closely with operation partners in identifying, investigate and prevent quality and compliance risk through tour, tier meeting, project and program. Improve FTR (first time right) and COPQ (cost of poor quality) metrics.
Other quality functions and projects as requested.
- 3+ years of related work experience in quality assurance, document control, quality compliance or relevant operation and business roles.
- Knowledge of ISO 9001, 13485 compliance, GMP, GDP, GLP a plus
- GMP Quality Assurance experience highly desired
- Ability to work independently or as part of a team, self-motivated, adaptable
- Excellent communication and attention to detail
- Bachelor's Degree
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.