Quality Scientist

Thermo Fisher Scientific•Detroit, MI

11d•Onsite

About The Position

As a Quality Scientist at Thermo Fisher Scientific Inc., you will have a unique opportunity to support a world-class life science manufacturing facility in Detroit. You will play a crucial role in ensuring the flawless quality of our Peptone products used in critical Biopharmaceutical applications. With your exceptional skills and expertise, you will perform routine analytical, physical, and microbiological testing and support the timely disposition of raw materials and finished goods, helping us uphold rigorous quality standards and meet the needs of our global customers.

Requirements

Bachelor of Science (BS) degree in Chemistry, Biology, Chemical Engineering, or related scientific field.
1+ years of prior experience in a Quality Control Laboratory setting in the Pharmaceutical/Biotech/Life Science industry.
Experience performing routine testing and supporting product disposition using analytical, physical, or microbiological methods.
Strong analytical skills with the ability to conduct laboratory Out-of-Specification investigations using scientific knowledge and statistical methods.
Working knowledge of ISO 13485:2016, FDA cGMP regulations, and associated quality system expectations.
Experience with batch record reviews and electronic Quality Management systems.

Nice To Haves

Knowledge of method qualification/validation principles and equipment qualification is preferred.
Familiarity with standard analytical technologies (e.g., HPLC, FTIR, TLC, ICP-MS) is desired.

Responsibilities

Perform Quality Control (QC) chemical and biological testing of raw materials and peptone finished products, including but not limited to product appearance, pH, bioburden, loss on drying, growth promotion, titration, and other physical and chemical assays.
Set up, operate, and maintain laboratory equipment in accordance with established procedures, methods, and calibration/maintenance requirements.
Accurately document test results, perform data analysis, and communicate findings to cross-functional partners in compliance with GMP and data integrity principles.
Support laboratory test method and equipment qualifications/validations in accordance with ICH Q2(R1), FDA guidance, and internal quality system requirements.
Draft, revise, and maintain standard operating procedures (SOPs), test methods, and other quality system documentation.
Conduct environmental monitoring of production areas, including sampling, testing, trending, and reporting.
Maintain an accurate and organized inventory of laboratory chemicals, reagents, standards, and consumables; procure supplies as needed to ensure uninterrupted testing activities.
Support manufacturing through batch record review, in-process quality monitoring, and collaboration with operations personnel.
Participate in internal and external audits and ensure ongoing compliance with site, regulatory, and industry standards.
Perform Quality Assurance (QA) support activities as needed, including material release and documentation review.