Engineer/Scientist I, QC at Thermo Fisher Scientific in Lenexa, Kansas

Job Description:

Work Schedule

First Shift (Days)



Environmental Conditions

Laboratory Setting



Job Description




About Thermo Fisher Scientific



Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science! Our mission is to enable our customers to make the world healthier, cleaner, and safer. With revenues of $20 billion, we have approximately 70,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies, as well as in environmental and process control industries. Our products and services help our customers tackle sophisticated analytical challenges, improve patient diagnostics, and increase laboratory efficiency. Visit www.thermofisher.com.


Job Title: Quality Control Scientist I
Position Location: Lenexa, Kansas
Day/Shift: Days, Monday - Thursday 7am - 4:30pm, Friday 7am - 11am



Position Summary:



The Quality Control Scientist I is responsible for all quality control aspects of finished product testing. The role ensures that the performance of finished products is in compliance with testing standards per IFU, SOPs, customer requirements, and regulatory guidelines. Additional responsibilities include documentation control per Quality Assurance compliance requirements.



Key Responsibilities:

• Perform and interpret microbiology testing, including growth promotion, biochemical, and AST, in accordance with ISO 17025 & 17034 Quality Management Systems and Quality Policies.


• Document testing results, determine disposition, and ensure accuracy in the SAP quality system.


• Maintain consistency in training in Master Control and enforce to all safety requirements and procedures.


• Establish and maintain SOP criteria for inspection/testing and assist in maintaining standards in accordance with GMPs, SOPs, and ISO regulations.


• Maintain department equipment, request consumables as needed, and supervise GMP compliance in the work environment.


• Collaborate closely with the Quality Assurance department and Customer Service Representatives to achieve timely product releases.


• Complete Stability Study testing per QA requirements and report any non-conforming results to the QC Team Leader or Quality Manager.


• Participate in the continuous improvement program within the department, including PMD assessments and Kaizens.


• Work effectively in a fast-paced laboratory setting and perform other duties as assigned.


• Support all company policies and contribute to achieving department goals.

• Possess at least a 4-year degree in biological sciences with coursework in microbiology or a 4-year degree with 5+ years of microbiology lab experience, required.


• A minimum of 1-2 years of combined experience in QC/QA, microbiology laboratory work


• Familiarity with FDA regulations for medical devices and the ability to follow written and verbal instructions.


• Proficiency in digital tools such as Microsoft Word and Excel. Experience with SAP is a plus.


• Ability to manage multiple tasks in an organized fashion and prioritize assignments.


• Excellent verbal and written communication skills in English and the ability to collaborate with different departments on quality testing parameters.


• Adaptability to learn new procedures, maintain a scientific and objective approach, and recognize deviations from requirements and standard practices.


• Availability to work weekend shifts when needed and willingness to put in overtime to complete tasks.


• Self-motivated, highly responsible, with strong teamwork and participation skills, and a high sense of responsibility.


• Critical thinking skills and the ability to work independently as well as within a small team, performing routine duties with minimal direction.