Thermo Fisher Scientific Document Control and Training Specialist II in Ward Hill, Massachusetts
Administer the Document Control System:
Maintain the system to keep compliance with ISO9001 requirements
Partner with department managers to ensure all employees understand the system
Guide Subject Matter Experts in writing and revising documentation required by the Quality Management System.
Ensure documents are reviewed as required by procedures
Generate and monitor metrics for report out in Management Review and use these metrics to address improvement opportunities.
Major participant in implementing an electronic document control system
Administer Training System, which includes:
Assist in improving the existing system to maintain compliance with ISO9001 requirements
Partner with department managers to develop training criteria for all positions.
Ensure that training is carried out as scheduled and that all training gaps are closed
Generate and monitor metrics for report out in Management Review and use these metrics to address improvement opportunities
Major participant in implementing an electronic training tracking system
Expertise with Document Control and Training as required by ISO 9001.
Participate in other QMS efforts such as CAPA, Non conformances, internal audits, change management, customer audits, etc.
Participate in PPI (continuous improvement) events.
Perform other duties as assigned.
Bachelor’s Degree in a technical field with at least 5 years of experience in a manufacturing environment or equivalent work experience.
3 years of experience as administrator of a Document Control system.
3 years of experience as owner of a Training system.
Excellent written communication and technical writing skills.
Knowledge of the most recent version of ISO9001.
Experience with QMS databases such as Master Control or TrackWise.
Skilled at reporting metrics showing performance and trending
Ability to manage numerous priorities and activities in parallel
Ability to review current processes and implement productivity and compliance improvements.
Strong “people skills” to be able to deal with various personalities and levels within and outside of the organization.
Excellent verbal and written communication skills; ability to write reports required.
Excellent organizational skills and be detail oriented.
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