Quality Control Stability Study Coordinator

Work Schedule

10 hr shift/days

Environmental Conditions

Laboratory Setting

Job Description

Company Information

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. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.  Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.  For more information, please visit www.thermofisher.com.

Job Description

Job Title:  Quality Control Stability Study Coordinator

Reports To:  Quality Control Manager

Group/Division:  SDG/MBD

Career Band:  Band 5

Job Track: Professional

Position Location:  Lenexa Kansas

Number of Direct Reports none

Day/Shift:  Monday – Thursday, 7am – 5:30pm OR Tuesday - Friday, 7am – 5:30pm

FLSA Status (Exempt/Non-Exempt):  Exempt

Position Summary:

The Stability Study Coordinator is responsible for conducting stability studies on culture media, AST, stains and reagent products. Perform testing against technical specifications, documenting, analyzing results and generating study reports. This role involves ensuring compliance with regulatory agencies’ guidelines.

Key Responsibilities:  

• Perform stability testing of finished and intermediate products manufactured in Lenexa.
• Develop study protocols, maintaining study documentation and reports
• Oversee the collection, labeling and storage of study samples.
• Review study data and prepare reports summarizing results for internal and customer use.
• Investigate out of specification results. 
• Ensure stability studies are conducted and documented in compliance with relevant regulatory requirements.
• Gain proficiency on testing of all product lines manufactured in Lenexa.
• Maintain consistency in training in Master Control.
• Responsible for maintaining department equipment and requesting consumables as needed.
• Exercise and monitor GMP and GLP compliance in work environment.
• Work closely with Quality Assurance department as a quality team.
• 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.
• Participate in achieving department goals.
• Support all company policies.
• Performs other duties as assigned.

Minimum Requirements/Qualifications:

• Possess at least a 4-year degree in the biological sciences. Must have course work in microbiology with a laboratory.
• A minimum combined 3-4 years of experience in related QC/QA, microbiology laboratory work in a laboratory setting, or an equivalent combination of education and experience.
• Previous experience with microbiological culture media, AST products, stains and reagents.
• Familiarity with FDA regulations for medical devices, ISO, USP and CLSI.
• Possess the ability to manage many tasks and in an organized fashion.
• Able to communicate effectively with a variety of departments regarding quality testing parameters.
• Possess intermediate computer skills, preferably with experience in Microsoft word to include Word, Excel and PowerPoint programs. Experience working in SAP is a plus.
• Listen to, and follow, written and verbal instructions in English.
• Able to adapt and to learn new procedures and to maintain a scientific and objective approach.
• Must be available to work overtime when needed.
• Self-motivated, highly responsible and possess a good teamwork spirit.
• Excellent verbal and written skills in English.
• Negative TB Test
• Pass Ishihara(Color Blind) Test