Thermo Fisher Scientific Quality System Document Control Administrator Assistant in Allentown, Pennsylvania

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.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/

Responsibilities:

  • Applies Good Manufacturing Principles in all areas of responsibility.

  • Demonstrates and promotes the companies vision.

  • Assist QSDC with the creation and updating of company procedures and forms that govern work processes. This includes editing and routing of documents for review and approval.

  • Assist with archiving process

  • Assist with audit preparation and audit support as required.

  • Maintain all GXP Documentation

  • Maintain SOP Binders such that they are accurate and up to date.

  • Tracks and monitors system issues to identify trends and propose solutions.

  • Assist with the initiation of periodic reviews for controlled documents by their due dates.

  • Update iComply as needed to support internal FCS training requirements.

  • Responsible for the day-to-day operation and support of the Validated LMS and supporting the site Domain Level Administrators (DLA).

  • Provides analysis of issues and training on the LMS.

  • Maintains and/or creates relevant site level LMS iComply items or systems as needed.

  • Maintains associated LMS items in a compliant state. (Ex. Curricula Reviews, Reports, addition and removal of Documents related to training in the LMS.

  • Proposes improvements to various LMS systems within span of control or escalates as necessary.

  • Troubleshooting technical issues for Tier l and Tier ll and escalating appropriate issues to the LMS administrator.

  • Tracks and monitors system issues to identify trends and propose solutions.

  • Sets up new DLAs in iComply with the appropriate permission/rights.

  • Attend monthly DLA meetings

  • Coordinates implementation of global procedures/guidelines/standards to ensure consistency, compliance and technical integrity of content and learning delivery using the LMS. Coordinates the deployment of forms and documentation required to support all learning content and recordkeeping.

  • Other duties may be assigned to meet business needs.

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 at 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.