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Quality Specialist I - Document Control and Training
Company: Thermo Fisher Scientific
Location: Eugene, OR
Employment Type: Full Time
Date Posted: 01/15/2021
Expire Date: 04/07/2021
Job Categories: Biotechnology and Pharmaceutical, Computers, Software, Government and Policy, Information Technology, Quality Control, Research & Development, Medical, Environmental
Job Description
Quality Specialist I - Document Control and Training

Thermo Fisher Scientific is the world’s leader in “serving science,” we enable our customers to make the world healthier, cleaner and safer. We are a $22 billion company with nearly 70,000 employees in 50 countries around the world. We serve primarily the pharmaceutical, biotechnology, and bio-research industries – which makes our clients organizations like hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as other environmental and industrial process control settings.

What will you do?

  • Perform document control-related functions, including but not limited to the processing of document change orders, as well as maintain documentation in accordance with ISO 13485 and Thermo Fisher Scientific policies and procedures;
  • Create Quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality;
  • Maintain Quality records according to Thermo Fisher Scientific policies and procedures;
  • Format Word and Excel documentation;
  • Ensure QMS compliance as a system administrator of the site’s Learning Management System;
  • Maintain training records for associates in accordance with Thermo Fisher Scientific policies and procedures;
  • Create, collect and record training events in the Learning Management System for Instructor-led, On-the-Job Training, Read and Understand, and any other trainings for associates;
  • Develop training requirements for associates with guidance from department supervisors and subject matter experts;
  • Support and manage updates to training requirements for new or revised processes or procedures;
  • Provide routine training compliance reports to functional site leadership;
  • Maintain OJT matrix to ensure tool reflects employee’s qualification status;
  • Support any additional Quality Management systems assigned within the Quality Specialist scope of work in alignment with the site strategy and goals; and
  • Performs any other tasks or projects as assigned.

How will you get here?

  • High School Diploma required. Minimum Bachelor’s degree in Chemistry, Biochemistry, or Bioscience with 0-2 years of Quality Assurance/Quality Control experience preferred. Demonstrated ability and/or additional experience may be considered in lieu of an undergraduate degree.
  • Minimum of 2 years of experience in a Pharmaceutical, Biotech or regulated environment. Familiarity with the life sciences industry is highly desired. Experience with Quality Systems software applications, including Learning Management Systems, is highly desired.

Knowledge, Skills, Abilities

  • Knowledge of quality system regulations/requirements (i.e. ISO 9001:2015, ISO 13485:2016).
  • Effective communication skills at all levels both written and verbal.
  • Ability to work with internal functional groups to ensure Quality Systems compliance.
  • Effective skills in analytical thinking and problem solving.
  • Ability to perform multiple tasks and to effectively manage competing priorities.
  • Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities, minimal supervision required.
Contact Information
Company Name: Thermo Fisher Scientific
Website: https://thermofisher.contacthr.com/...
Company Description:

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