Thermo Fisher Scientific Quality Systems Documentation Technician in Lenexa, Kansas

Job Description

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com at http://www.thermofisher.com/ .

Position Summary:

Quality Systems - Documentation Technician is responsible for assisting in the preparation, editing and coordination of department files, database systems, procedures, forms and correspondence for the Quality Systems Department.

Key Responsibilities:

  • Assist in the preparation, formatting, and execution of Standard Operating Procedures, Forms, Training Programs and Records, and any other departmental projects.

  • Disposition documents in a timely manner.

  • Organize and maintains department files, including internal forms, SOPs, customer/vendor files and database maintenance.

  • Operate Master Control Quality Management Systems software suite, including, but not limited to collaboration and approval of documents

  • Appropriately escalates any issues to Quality and Production management teams.

  • Participate in general review and update of Standard Operating Procedures according to Food & Drug Administration Quality System Regulations, ISO 13485, and internal procedures.

  • Maintains standards in accordance with cGMP's/SOP's and ISO regulations.

  • Follows and supports all company policies.

  • Performs other duties as assigned.

Minimum Requirements/Qualifications:

  • Possess high school diploma or GED minimum, Associates degree preferred.

  • Course work in the sciences is a plus.

  • Strong attention to detail and highly organized.

  • Possess proficient computer skills, preferably with experience in Word, Excel and SAP programs.

  • Excellent analytical, prioritization, multi-tasking, problem-solving, and communication skills.

  • Familiarity with FDA regulations for medical devices is a plus.

  • Must be able to communicate, both written and verbally, using the English language.

  • Must be able to comprehend and follow both written and/or verbal English communications.

  • Works well independently and within a team environment.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.