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Thermo Fisher Scientific Quality Specialist I in Lenexa, Kansas

Job Title: Quality Specialist I

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale. Join 100,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Division/Location Specific Information

The role is responsible for Document Control Management at Lenexa, Ks which manufactures culture media and other microbiological diagnostic products serving customers in the pharmaceutical, food and clinical laboratories. This operation is part of our Microbiology Division (MBD), part of our Specialty Diagnostics Group (SDG).

Discover Impactful Work:

We are looking for a dedicated, expert and resourceful Quality Specialist to support the site’s day to day document control system processes and ensure compliance to all applicable standards.

A Day in the Life:

  • Responsible for overseeing established document control workflow in Master Control to complete the request for changes in timely manner. This includes but not limited to SOPs, forms, specifications, standard works, IFUs, etc.

  • Support the preparation, formatting and implementation of controlled documents via Master Control in accordance with policies and procedures.

  • Revise QMS related documents as required.

  • Interact with appropriate departments to resolve change requests and discrepancies

  • Provide basic training on Master Control processes to site personnel

  • Provide general and technical support and assist problem-solving issues for document system (Master Control) for site personnel. Work with IT when required.

  • Assist with divisional document reviews ensuring that document changes which impact multiple sites are appropriately addressed to make any changes as required for site documents

  • Drive continuous improvement of Document Control process by employing Practical Process Improvement (PPI) concepts, running metrics, reporting and communicating internally to Leaders and diverse audiences

  • Determine required approvers and route corresponding documents in Master Control appropriately

  • Prepare QMS documents, training records, and other items within Master Control for audit support.

  • Participate in site internal and external audits as required

  • Transfer documents to new approved templates and review for accuracy

  • Administer program for logbooks and keeping accurate records of those logbooks

  • Manage the archive system for documents (both electronic and hardcopy) including management of offsite submission/retrieval of documentation.

  • Cross train as needed including back-up for local Master Control site administrator and batch record review

  • Other job duties as needed

How will you get here?

  • Requires a minimum of 3 years relevant experience in a regulated document control environment.

  • Strong working knowledge of computer applications and current software (Microsoft Excel, Outlook, Word, PowerPoint, Teams, etc).

Education

  • High school diploma or equivalent required.

  • Associate’s degree from accredited college/university or equivalent experience.

Knowledge, Skills, Abilities

  • Experience with Master Control and electronic document control systems preferred

  • Works independently on new and on-going assignments and within a team environment

  • Identifies and solves problems using established business rules and procedures

  • Strong attention to detail and highly organized

  • Strong verbal and written communication skills

  • Continuous improvement minded

  • Knowledge and experience of quality standards for ISO 13485 and/or FDA a plus

  • Experience in SAP a plus

  • While performing duties of the job, the employee is required frequently to stand

  • May occasionally be required to lift or move up to 10 lbs

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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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