Work Schedule

Environmental Conditions

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 $12 billion, we have approximately 39,000 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. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.

Job Title:  Quality Control Scientist I

Reports To:  Quality Control Supervisor

Group/Division:  MBD

Career Band:  Band IV

Job Track: Quality Assurance

Position Location:  Lenexa Kansas

Number of Direct Reports none

Day/Shift (if applicable): M-F 

FLSA Status (Exempt/Non-Exempt):  Exempt

Position Summary:

Responsible for all quality control aspects of finished product testing. Ensure that performance of finished product is in compliance with testing standards per IFU and SOP's in addition to customer requirements and regulating agencies' guidelines. Documentation control duties per Quality assurance compliance requirements.

Key Responsibilities:

• Review and maintain product compliance specifications, documentation control.
• Perform and interpret microbiology testing including growth promotion, biochemical, AST.
• Gain proficiency on all performance benches.
• Documentation of testing results and determining disposition.
• Maintain consistency in training in Master Control.
• Establish and maintain SOP criteria for inspection/testing.
• Responsible for maintaining department equipment and requesting consumables as needed.
• Exercise and monitor GMP compliance in work environment.
• Work closely with Quality Assurance department as a quality team.
• Execute Stability Study testing in accordance with QA requirements.
• Work in conjunction with Customer Service Representatives to achieve on time product releases for standing orders and special products.
• Work with the continuous improvement program within the department.
• Work closely with a team in a fast-paced laboratory setting.
• Understand and exercise all safety requirements and procedures.
• Assists in maintaining standards in accordance with GMP's/SOP's and ISO regulations.
• Participate in achieving department goals.
• Support all company policies.
• Performs other duties as assigned.

Minimum Requirements/Qualifications:

• 1. Possess at least a 4-year degree in the biological sciences. Must have course work in microbiology with a laboratory or a 4-year degree with 5+ years of microbiology lab experience.
• 2. A minimum combined 1-2 years of experience of in related QC/QA, microbiology laboratory work in a laboratory setting, or an equivalent combination of education and experience.
• 3. Familiarity with FDA regulations for medical devices.
• 4. Possess the ability to manage many tasks and in an organized fashion.
• 5. Able to communicate effectively with a variety of departments in regard to quality testing parameters.
• 6. Possess intermediate computer skills, preferably with experience in Microsoft word to include Word, Excel and PowerPoint programs. Experience working in SAP is a plus.
• 7. Listen to, and follow, written and verbal instructions.
• 8. Able to adapt and to learn new procedures and to maintain a scientific and objective approach.
• 9. Must be available to work weekend shifts when needed.
• 10. Self-motivated, highly responsible and possess a good teamwork spirit.
• 11. Excellent verbal and written skills in English.

Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)

• Candidate must be a good time manager.
• Candidate must be willing to put in overtime when needed to complete tasks.
• Candidate must be a good team player/participant on teams.
• Candidate must have a high sense of responsibility.
• Candidate must possess critical thinking skills.