About Thermo Fisher Scientific:
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and 55,000 employees in 50 countries. 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 and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
• Promote implementation of manufacturing controls by developing and facilitating use of standardized batch record templates
• Perform document review/approval on all new/revised batch records
• Ensure that developed procedures and specifications are appropriate and followed
• Archive, store and maintain all document files to comply with Corporate and Site policies in a state of audit readiness
• Perform production Batch Record Review, product release, and investigate discrepancies
• Address document issues with production supervisors, quality management, and other appropriate groups
• Monitor document adherence to quality and good documentation practices standards, report associated metrics and recommend batch record improvements per spot-check audits.
• Provide guidance and training to manufacturing and other functions in implementing good documentation practices; assist in setting site policies for GDP
• Assist with internal and external audits
• Perform other duties as may be required or necessary
• Bachelor’s degree preferred in Business, Science Technical Field or equivalent experience
• 2-5 years of relevant experience in a Quality Assurance or related role.
• Demonstrated use of Quality tools/methodologies.
• Good working knowledge of FDA, GMP, ISO 13485, and ISO 9001 regulations.
• Good organization skills and ability multi-task, drive for results and make sound business decisions independently.
• Strong knowledge of using Microsoft Excel and Word required.
• Flexible to working any shift swing or graveyard shift as needed and including weekends and during major holidays.
Nice to Have
• ASQ (American Society of Quality) certification in Quality Process (CQPA) or Quality Technician (CQT)