QC Scientist II

Thermo Fisher Scientific•Saint Louis, MO

23h•Onsite

About The Position

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. Location/Division Specific Information St. Louis, MO How will you make an impact? As a QC Scientist II, you will do important work that makes a real-world impact. Your efforts will help in finding cures for cancer, protecting the environment, and ensuring food safety. You will be supported in achieving your career goals.

Requirements

BS/BA in biology, biochemistry, chemistry, or a related science field, or a four-year degree with meaningful experience.
Minimum of two (2) years of experience in cGMP or another highly regulated industry.
Experience with bioburden and/or endotoxin assays
Knowledge of cGMP regulations and international health authority guidelines.
Proficient in Microsoft Office (Word and Excel).

Nice To Haves

Knowledge of compendial requirements for raw material testing is desired
Experience with Smartsheet and Trackwise systems is desired

Responsibilities

Create QC Raw Materials (QCRM) specification documents in accordance with internal SOPs and external regulations.
Review batch records, process validation protocols/reports, technical transfer documents, and product specifications with high attention to detail and assess the impact of changes on the testing laboratory
Collaborate with QCM laboratory scientists to support laboratory needs and questions.
Review bioburden and endotoxin Raw Data for the QC Microbiology (QCM) laboratory
Generate Certificates of Testing for bioburden and endotoxin results
Support QCM testing by providing matrices, SOPs, and other testing protocols

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