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Quality Control Stability Study Coordinator
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Thermo Fisher ScientificLenexa, KS, United States- Full-time
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 :