Work Schedule
Flex 12 hr shift/daysEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
DESCRIPTION:
Join our Quality Control team at Thermo Fisher Scientific where you'll make meaningful contributions to our mission of enabling customers to make the world healthier, cleaner and safer. As an Engineer/Scientist II, QC, you'll perform testing and analysis to ensure product quality while working with state-of-the-art analytical equipment in a GMP environment. You'll conduct testing of raw materials, in-process samples, and finished products using various analytical techniques, evaluate test data, document results, and participate in continuous improvement initiatives. This role offers excellent opportunities for professional growth while working alongside colleagues who share your commitment to science and quality.
REQUIREMENTS:
• Bachelor's Degree plus 4 years of experience, preferably in pharmaceutical/biotech industry
• Preferred Fields of Study: Microbiology, Biotechnology, Biology, Molecular Biology or related scientific field
• Additional certifications in Quality Control/GMP practices beneficial
• Strong knowledge of GMP regulations and quality systems requirements
• Experience with microbiological and biochemical testing methods (Sterility Test, Endotoxin & Bioburden). Experience in performing Microbiology Method verification / validation.
• Demonstrated expertise in data analysis and investigation of out-of-specification results
• Strong documentation skills and proficiency with laboratory information management systems
• Knowledge of relevant regulatory standards (ISO, FDA, USP, EP)
• Excellent attention to detail and ability to follow written/verbal procedures accurately
• Strong organizational and time management skills
• Ability to work both independently and collaboratively in a team environment
• Proficiency in Microsoft Office applications
• Clear written and verbal communication skills in English
• Experience with laboratory automation systems preferred
• Knowledge of Lean/Six Sigma principles beneficial