QC Scientist I

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.

SUMMARY:

Provides moderately complex analyses in a microbiological environment within defined procedures and practices. Performs microbiological methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or method development testing. Supports internal development and/or manufacturing operations. Makes detailed observations, reviews documents, and communicates test results; recommends solutions.

EDUCATION:

Bachelor’s degree in physical science, preferably in Microbiology, Biology, or Natural Science.

EXPERIENCE:

Typically requires a minimum of 2 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. Experience with aseptic technique and common office software.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

• Conducts moderately complex microbiological testing of pharmaceutical raw materials, packaging components, finished products, environmental monitoring and stability samples by internally developed and compendial test methods.
• Completes Microbiology Method Development Protocols that are written internally by Microbiology Management and signed off with QA and Client approval.
• Recognizes and reports out-of-specification or unexpected results and non-routine product problems; recommends solutions.
• Maintains and troubleshoots analytical instrumentation as needed.
• Clearly and accurately communicates the results of work by documenting the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.
• Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
• Writes SOPs and other instructional documents.
• Cleans and organizes work area, instrumentation, and testing materials.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.