When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
 
How will you make an impact?
Performing Control testing of products at our Frederick, MD location
 
What will you do?
 

• Plans and performs quality control testing of products using Flow Cytometry and ELISA assay.
• Plans and performs quality control testing of reagents and kits utilizing qPCR (7500, 7900, Quant Studio), microplate reader (Varioskan Lux, Spectramax M5) among other instruments.
• Collects and analyzes data for final disposition using preapproved documentation as well as troubleshoots assays.
• Assist QC Manager with managing QC schedules
• Participate in QC Method Validation and Method Transfer activities
• Train new and existing QC scientist on new and existing Quality Control test methods.
• Performs and documents equipment maintenance.
• Update QC test methods, QBR’s, forms, and SPC’s to align with current laboratory practices and improvements
• Maintain laboratory testing inventory and supplies
• Write and execute stability protocols and reports.
• Perform peer review of QC data packets
• Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) via TrackWise and performs root cause investigation and analysis for OOS and complaints.
• Ensuring the laboratory is well-stocked and resourced
• Recording and sometimes interpreting results to present to senior colleagues
• Using computers and performing mathematical calculations for the preparation of graphs
• Following and ensuring strict safety procedures and safety checks
• Perform other activities as directed by QC Manager

• Bachelor’s degree in biology, Molecular Biology, Biochemistry, Chemistry, Life Sciences, or other related discipline required.
• 5+ Years of industry experience in biotech, pharma or other related experience.
• 3-5 years of working in a regulatory environment such as clinical laboratory and/or cGMP Quality Control Laboratory experience
• Experience performing Flow Cytometry tests and ELISA assay is required.
• Experience with pipetting techniques
• Proficiency in Excel
• Ability to perform independently, take initiative and work as part of a team.
• Ability to work in dynamic, fast paced team environment.
• Excellent communication/interpersonal and presentation skills.
• Experience writing & reviewing technical documentation.
• Experience in working with FDA, ISO 13485 and cGMP regulations.
• Experience with the following instrumentation qPCR (7500, 7900, Quant Studio), microplate reader (Varioskan Lux, Spectramax M5) among other instruments.