The QA Change Analyst will be responsible for administration of the Change Control and document control in Thermo Fisher Scientific Bedford site. This includes maintaining the document control process for procedures, work instructions, forms, specification, and batch records. This role will be a key individual for electronic system based change control processes, including initiation, facilitation and implementation. Ability to prioritize and execute changes with high level of attention to detail required. You will be a self-starter and able to work with little direct oversight. Regular reporting of analytics and metrics will be required.
- Administer the Document Control System:
- 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 and approved 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 2 years of experience as administrator of a Document Control system. 3 years of related experience preferred.
- Knowledge and experience with mainstream electronic Document Control system highly desired: Agile, Trackwise, Master Control 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.