Thermo Fisher Scientific Manager, Document Control in Fremont, California

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.

The Manager, Document Control will be responsible for assuring company-wide compliance with FDA/GMP/QSR and ISO 13485/CMDR/CE commitments. Oversee updates and communicate changes to document control processes. Lead training record system implementation, assessment and improvements. Mentor and develop Record and Document Control staff involved in the preparation, documentation and dissemination of controlled documents in accordance with GMP standards.

Major Responsibilities:

  • Oversee Master Control administration, performance, reporting and updates.

  • Ensure compliance with Federal, State and Local regulations pertaining to training, GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory agencies through effective management of internal audit functions.

  • Manage Document Control as well as Records Management and Processes.

  • Assist Department Managers to develop plan and revise procedures and implement changes/programs for the following functional areas: QS/Compliance, Document Center, Labeling, Regulatory Affairs and other functional areas.

  • Ensure effective interactions at a departmental level to efficiently incorporate departmental activities into overall company strategies and quality systems.

  • Assist in establishing and conducting companionway training related to GMP/QSR and EU regulations pertaining to ISO13485/CMDR/CE.

  • Maintain and follow proper ISO procedures (ISO 13485 2003, ISO 14971 and GMP requirements pertaining to medical devices/IVDs).

  • Assist to coordinate/manage training process.

  • Assist in activities relating to Regulatory Affairs (RA) with RA team.

  • Provide Quality Management Systems assistance for all facilities.

  • Assist during FDA inspections, Notified Body, customer audits and other third party Quality System evaluations.

  • Assist to author, change and update Quality Manual and QA procedures as applicable.

  • Assist to provide training on QM system process, including general Quality System and GMP training.

  • Participate in project management/performance team meeting on behalf of the quality department in order to provide ideas, methods or processes for unit/company performance improvement.

  • Perform Annual Product reviews by families to document trends and review risk documents.

  • Performs other job-related duties as assigned.

  • Responsible for overseeing the Document Control and Packaging department staff.

  • Will supervise 5 to 10 subordinates.

  • Involve in developing, modifying and executing company policies which affect immediate operations and may also have companionway effect.

Minimum Requirements/Qualifications:

  • Bachelor’s Degree plus a minimum of 5 years previous Document Control experience in an FDA-regulated environment with a minimum of 2-3 years supervisory/managerial experience.

  • Thorough knowledge and understanding of Quality Systems requirements and ISO 13485. Previous FDA audit experience a plus.

  • Solid understanding and experience using an electronic document control system.

  • Solid communication skills with the ability to communicate at all levels of the organization both orally and in writing.

  • Solid organizational skills with ability to multi-task and balance complex and routine work activities. Ability to prioritize and delegate.

  • Demonstrated ability to lead projects and get results through others. Proven housebuilding skills. Ability to negotiate and influence others.

  • Experience validating an electronic document management system, preferably Agile.

  • Solid computer skills using MS Office, Photoshop, Adobe, Quark or other related software, various related file management software, Outlook and the internet. Skilled in flow charting.

At Thermo Fisher Scientific, each one of our 55,000 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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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.