Scientist II, QC Microbiology

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to 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.

Location/Division Specific Information

St. Louis, MO / Drug Substance Division - The Drug Substance Division is one of the five divisions that make up the Pharma Services Group. We specialize in both small and large molecule development and commercial drug substance services. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.

Discover Impactful Work:

Provide routine analyses in microbiology by following standard practices. Perform microbiological testing of in-process samples, raw materials, buffers, media, etc. per compendial methods. Support internal development and/or manufacturing operations. Make detailed observations and reviews, documents, and communicate test results.

Work Schedule: Monday- Friday

A day in the Life:

• Conduct routine bioburden testing of solutions and raw material per compendial methods and established methods.
• Recognize and report out-of-specification or unexpected results. Clearly and accurately communicate the results of work by generating documentation of the testing/analysis and acquired results. Record and report results of analysis in accordance with prescribed lab procedures and systems.
• Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• Contribute to writing of SOPs if needed.
• Perform daily lab cleaning, preventative maintenance of equipment, ordering of supplies, and autoclaving of equipment.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintain the necessary compliance status required by company and facility standards

Keys to Success:

Education

• Bachelor's degree required in a scientific field, preferably a Microbiology or Biology.

Experience

• 2+ years experience working in a cGMP and lab environment or equivalent experience.

Knowledge, Skills, Abilities

• Knowledge of GMP regulations in cGMP manufacturing environment preferred.
• Excellent problem solving and critical thinking skills
• Excellent organization and planning skills.
• Strong attention to detail and ability to adhere to standard procedures.
• Ability to function in a continually evolving environment.
• Experience in writing QC investigations
• Experience in managing projects
• Ability to work in team environment as well as independently