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Job ID :
54893BR
Location :
US - Kansas - Lenexa
:
Job Description

Key Responsibilities:

  • Audits (reviews) manufacturing documentation (hardcopy and online) for accuracy and completion.
  • Attends meetings to give feedback to Product Value Stream teams
  • Expedite documentation issues to ensure timely disposition of products.
  • Appropriately escalates any product issues to Quality and Production management teams.
  • Leads day-to-day activities to ensure swift and accurate completion of product disposition activities.
  • Collaborates with the manufacturing, planning, and distribution departments to troubleshoot and solve problems.
  • Maintains standards in accordance with cGMP's/SOP's and ISO regulations.
  • Supports tracking departmental metrics and meeting departmental goals.
  • Supports training of new employees on process flow and documentation.
  • Manage a continuous improvement program within the Quality Assurance department.
  • Follows and supports all company policies.
  • Performs other duties as assigned.

Minimum Requirements/Qualifications:

  • Possess high school diploma or GED minimum, Associates degree preferred.
  • Possess proficient computer skills, preferably with experience in Word, Excel and SAP programs.
  • Course work in the sciences/engineering is a plus.
  • Document review experience is preferred.
  • Familiarity with FDA regulations for medical devices is a plus.
  • Possess the ability to manage many tasks in an organized fashion.
  • Listen to, and follow, written and verbal instructions.
  • Possess excellent oral and written communication, and problem-solving skills.
  • Works well independently and within a team environment
*IND-SDG


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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