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Job ID :
66093BR
Location :
US - California - San Jose
:
Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

What will you do?
As Manager Document Control and Training, you will be responsible for overseeing the Document Control, Training & Records Management team, processes, system administration, performance, reporting and updates. The manager will have 5 to 10 direct reports. Major responsibilities include:
  • All functions related to document control such as part numbers, engineering change orders and deviations, revision control, coordination of several electronic databases and internal customers to manage change control priorities.
  • All functions related to quality system training and qualification programs and ensure the training effectiveness of the program by developing and implementing effective processes and tools for identifying training needs, developing training content, monitoring and reporting compliance to the program
  • Apply PPI to drive continuous improvements for all processes related to change management, training and records management
  • Liaison with Corporate Records Management as site Records Manager
  • Manage, mentor, and develop staff involved in the preparation, documentation and dissemination of controlled documents, records management & training in accordance with regulations & ISO standards
  • Support Regulatory agency inspections and other external/internal audits. Provide subject matter expertise during inspections and audits; investigate and respond to Quality System issues identified
  • Ensure compliance with all relevant regulations & standards such as GMP/QSR, ISO9001/ISO13485 through effective change management
  • Work on complex assignments with high degree of independence; provide recommendations and resolve problems
  • Performs other job-related duties as assigned

How will you get here?
Qualifications/Experience
  • Bachelor’s Degree plus 5 years of experience in Document Control, Records & Training management experience in an ISO 9001 environment
  • 3+ years of experience managing, leading and developing a team
  • Thorough knowledge and understanding of Quality Systems requirements and ISO 9001
  • Experience in a FDA-regulated, ISO 13485, or other highly regulated environment is preferred
  • Experience using electronic document control & training system

Skills
  • Solid computer skills using MS Office (Word, Excel, PowerPoint, Visio). Photoshop, Adobe or other related software, file management software, Outlook and the internet skills preferred
  • Outstanding communication & presentation skills with the ability to communicate at all levels of the organization both orally and in writing
  • Excellent organizational skills with ability to multi-task and balance complex and routine work activities
  • Demonstrated ability to lead projects, prioritize, and effectively achieve results through delegation
  • Proven team building skills
  • Ability to negotiate and influence others

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today http://jobs.thermofisher.com



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.
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