Quality Assurance Engineer II – Document Control

Job Description-

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Division

Laboratory Chemicals Division (LCD) is part of the Life Sciences Solutions Group (LSG) and provides smart chemistry solutions for the pharmaceutical, agrochemical, diagnostic, detection, electronic, fuel cell, paints and coatings markets.

How will you make an impact?

Reporting to the Senior Manager, QA you will be responsible for the administration of the Document Control and Training systems of Thermo Fisher Scientific Laboratory Chemicals. This includes maintaining the document control process for procedures, work instructions, forms, specification, and batch records. It also includes maintaining the training documentation system for all Quality Management System related training. This position is responsible for a common system at two sites. Managing multiple priorities while partnering with multiple departments is 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.

What will you do?

Manage 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.
• A major participant in implementing an electronic document control system

Manage 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
• Expertise in 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., as required
• Participate in PPI (continuous improvement) events.

How will you get there?

• Bachelor’s Degree in Science or Engineering

• 1+ years of experience in a manufacturing environment or equivalent work experience.

• 1+ years of experience as an administrator of a Document Control system.
• 1+ years of experience as owner of a Training system.
• Experience with QMS databases such as Agile and Trackwise preferred

Knowledge, Skills, Abilities

• Excellent written communication and strong technical writing skills a must.
• Knowledge of the most recent version of ISO9001. FDA GMP experience is a plus.
• 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.