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Job ID :
44233BR
Location :
US - New Jersey - Bridgewater|US - New Jersey - Fair Lawn
:
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.

This position will be responsible for improvement and management of the Document Control and Training systems of ThermoFisher Scientific, Laboratory Chemicals in New Jersey. This includes improving, updating, and implementing the document control process for procedures, work instructions, forms, specifications, QC testing documents and batch records. It also includes improving, updating, and implementing the training documentation system for all Quality Management System related training. This position is responsible for a common system at two sites. Project management skills and managing multiple priorities while partnering with multiple departments are a must. Candidate must be a self-starter and able to work with little direct oversight. Regular reporting of analytics and metrics will be required.

Major Responsibilities:

  • Manage the Document Control System:
    • Improving the existing system to maintain compliance with ISO9001 and 21CFR820 requirements
    • Guide department managers and Subject Matter Experts in writing, reviewing, approving, updating and obsoleting documents (templates, GDP, procedures, etc.).
    • Approve document changes
    • Ensure documents are periodically reviewed for accuracy
    • Generate and monitor metrics for timely completion of document change and report out monthly, in Management Reviews. Use metrics to address improvement opportunities.
    • Ensure documents are appropriately controlled and monitored
    • Major participant in implementing an electronic document control system, including requirements, testing, training, access
    • Owner of Document Control process and associated tools
    • Train and assess competencies of employees to the Document Control process and tools
  • Manage Training System, which includes:
    • Improving the existing training system to maintain compliance with ISO9001 and 21CFR820 requirements
    • Partner with department managers to develop training criteria and requirements for all positions (skill and roll based training), and ensure trainers document completed training.
    • Enter completed training records
    • Monitor compliance to training requirements and ensure that training is completed by individuals as scheduled and that all training gaps are closed
    • Generate and monitor metrics for compliance report out in Management Review and use these metrics to address improvement opportunities
    • Major participant in implementing an electronic training tracking system
    • Expertise with Training process ownership, creation, implementation, improvement as required by ISO 9001 and 21CFR820.
    • Collaborate with functional areas to ensure training is performed as needed and documented accordingly.
    • Owner of Training process and associated tools
    • Train and assess competencies of employees to the training process and tools. Training may be performed for other QMS processes.
    • 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 Requirements/Qualifications:
BS in a technical field with at least 5 years of experience in a manufacturing environment. 3 years of experience as owner of a Document Control system. 3 years of experience as owner of a Training system. Significant experience may be considered in place of degree. Excellent written communication and technical writing skills. Knowledge of the most recent version of ISO9001 and pending regulatory changes. Experience auditing to 21CFR preferred. Technical writing and training experience preferred.

Non-Negotiable Hiring Criteria:
  • Proficient knowledge of Document Control and Training processes in accordance with standards such as ISO9001 and 21 CFR 820
  • Process creation and implementation experience required for both Document Control and Training (experience as trainer plus)
  • Experience with QMS databases such as Master Control and TrackWise, including process improvement, user requirements, user acceptance testing.
  • Technical writing experience and skills a plus
  • Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus
  • Ability to manage numerous priorities and activities in parallel (project management)
  • 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.
  • Position will divide time between Bridgewater, NJ and Fair Lawn, NJ sites



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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