Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)
Job Description
Location/Division Specific Information
Thermo Fisher Scientific Inc. is looking for a highly motivated QC Scientist II with strong work ethics to join our team in St. Louis, MO. As a member of the Environmental Monitoring (EM) group, you will contribute significantly to maintaining the quality and safety standards of our commercial and clinical biologics.
How will you make an impact?
As part of this role, you will regularly monitor the environment in clean rooms and controlled spaces to evaluate and analyze microbial control. Your accurate assessments will support the smooth production of our products, promoting health, cleanliness, and safety worldwide.
What will you do?
Perform routine environmental monitoring of viable/non-viable air, contact surface, water, and gases in accordance with our site procedures.
Perform plate reading and verification of results.
Investigate deviations, excursions, and trends using the Trackwise quality system.
Write/edit standard operation procedures and sampling protocols for performance qualifications.
Detail all activities to meet Current Good Manufacturing Practices (cGMP) requirements and perform document reviews and revisions.
Compile quarterly data into reports to be presented during regulatory audits.
Interpret data results using concepts of microbiology, industry standards, and site standard operating procedures (SOPs) and policies.
Complete preventative maintenance and work notification tasks on time, and perform equipment testing and routine troubleshooting.
Prioritize tasks based on production schedules, ensuring efficient and timely completion.
Identify deviations and contribute to investigations and root cause analyses. Document deviations and events in appropriate systems.
Actively participate in 1-1 meetings, department meetings, and other relevant gatherings to facilitate area needs based on changes.
Who we are looking for: experience, skills & abilities
To be successful in this role, you should have:
Education
A Bachelor's degree in Biology, Chemistry, Biochemistry, or a related field.
Experience
2+ years experience in Environmental Monitoring or QC Microbiology at a minimum. Candidates with more experience preferred.
5+ years of cGMP experience in Non-Quality Control roles will be considered as long as they hold a relevant Bachelor's degree or equivalent experience.
Knowledge, Skills, Abilities
Strong communication skills, both verbal and written.
Ability to stand for 4+ hours at a time.
Familiarity with cGMP practices, aseptic techniques, or microbiological concepts is advantageous.
Diverse knowledge of industry standards such as ISO, ICH, FDA, and USP.
Proficiency with MS Office (Word, Excel, PowerPoint, etc.).
Strong prioritization skills to manage multiple tasks effectively.
A strong inclination towards collaboration and proficiency in team-oriented environments.
Creative problem-solving abilities to address challenges and find innovative solutions.
At Thermo Fisher Scientific, we are dedicated to encouraging an inclusive and diverse workplace. We firmly believe that by bringing together individuals with varied backgrounds, experiences, and perspectives, we can fuel technological innovation, expedite research, and provide vital support to patients. Join our team and embark on your journey today!
