QC Scientist II

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do exciting work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create meaningful contributions to the world.

Essential Functions

• Perform environmental monitoring of a biological production facility according to written procedures, while fully gowned, including operational monitoring and personnel monitoring during aseptic processing and filling
• Recognize and report out-of-specification or unexpected results.
• Record and report results of analysis in accordance with prescribed lab procedures and systems.
• Qualify and perform/train junior staff on microbiological testing such as bioburden, bacterial endotoxin and biological indicator testing
• Draft SOPs, Test Records, Qualification Protocols and Summary reports and any supporting documents (Reagent Preparations, Equipment SOPs etc)
• Order laboratory supplies and maintain required inventory according to SOPs
• Perform laboratory and equipment cleaning and preventive maintenance and calibration
• Read and report microbiological test results
• Maintain and ensure safe laboratory practices. Also drafts and reviews Job Hazard Analysis for assays.
• Complete other assigned duties which include sample logging and assisting with shipment preparations
• Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• 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 vital compliance status required by company and facility standards.
• Take part in process improvement initiatives & having a voice within the department

Education

• Bachelor’s degree in science; preferably Microbiology or Biology, or equivalent years of proven experience.

Experience

• A minimum of three years of work experience within the biological and/or pharmaceutical industry. A graduate degree and appropriate hands-on college coursework may substitute at an equivalent rate for required experience
• Equivalent experience working in a cGMP environment preferred
• Hands on experience with aseptic technique, light microscopy, bioburden testing, bacterial endotoxin testing and general microbiological techniques preferred

Knowledge, Skills, Abilities

• Knowledge of GMP regulations in cGMP manufacturing environment preferred
• Excellent problem solving and critical thinking skills
• Excellent organization and planning skills

Salary : $40 - $0