Thermo Fisher Scientific Document Control and Training Specialist II in Ward Hill, Massachusetts

Job Description

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.

Minimum Qualifications:

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.

Preferred Qualifications:

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.