The Lead QA Change Analyst will be responsible for managing the Change Control and Document Control processes in Thermo Fisher Scientific Bedford site. This includes managing the change control process for procedures, work instructions, forms, specification, batch records, part creation/modification and other system configurations including Agile and SAP. This role will be the responsible person for electronic system based change control processes, including initiation, facilitation and implementation. Managing multiple priorities while partnering with multiple departments are a must. You will be a self-starter and able to work with little direct oversight. Regular reporting of analytics and metrics will be required.
- Manage and administer the site Change Control and Document Control Systems:
- Maintain the system to keep compliance with ISO9001 and 13485 requirements
- Guide Subject Matter Experts in writing and revising documentation required by the Quality Management System.
- Ensure documents are reviewed, approved and implemented as required by procedures
- Ensure parts and system configurations are reviewed, approved and implemented as required by procedures
- Generate and monitor metrics for report and use these metrics to address improvement opportunities.
- Lead responsibility in managing an electronic document control system
- As needed, participate in other QMS efforts such as CAPA, Non conformances, internal audits, change management, customer audits, etc.
- Participate in PPI (continuous improvement) events, own and drive improvement in Document Control process.
- Perform other duties as assigned.
- Bachelor’s Degree with at least 3 years of experience as administrator of a Document Control system. 5 years of related experience preferred.
- Knowledge and experience with mainstream electronic Change Control system highly desired: Agile, Trackwise, Master Control, SAP etc.
- Excellent written communication and technical writing skills.
- Knowledge of the document control compliance to ISO9001 required. Experience with ISO 13485 or GMP/QSR document control process highly desired.
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.