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Thermo Fisher Scientific · 2 days ago
Quality Scientist
Detroit, MI
Full-time
Onsite
Mid Level
2+ years exp
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Responsibilities
Perform Quality Control (QC) chemical and biological testing of raw materials and peptone finished products.
Set up, operate, and maintain laboratory equipment following standard procedures and methods.
Handle documentation related to Quality Control, including data analysis, test data recording, and interdepartmental communications.
Conduct and take responsibility for laboratory test method validations, adhering to Q2 (R1) ICH and FDA guidelines.
Write or revise standard quality control operating procedures and quality system documentation.
Conduct environmental monitoring, testing, trending, and reporting for production.
Write technical reports and documentation for change management records and out-of-specification analyses.
Assist in purchasing lab supplies and support subcontractors' activities related to lab requirements.
Support manufacturing batch record review and perform quality monitoring rounds on the manufacturing floor.
Support internal and external audits and ensure compliance with site and industry standards.
Lead/support quality walk-throughs (Gemba) to enhance compliance.
Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
Qualification
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Required
Bachelor of Science (BS) Degree in Analytical Chemistry, Chemical Engineering, or related scientific field, or equivalent experience.
2-3 years of prior experience in a Quality Control Laboratory setting in the Pharmaceutical/Biotech/Life Science industry.
Experience with the release and disposition of products using analytical, physical, or microbiological methods.
Good analytical skills with the ability to conduct laboratory Out-of-Specification investigations using scientific knowledge and statistical methods.
Proven validation proficiency and knowledge of equipment qualification.
Understanding of ISO 13485:2016 standards and FDA cGMP regulations.
Experience with batch record reviews and electronic Quality Management systems.
Preferred
Familiarity with standard analytical methods such as HPLC, FTIR, TLC, and ICP-MS is desired.
Benefits
Medical, Dental, & Vision benefits from Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement available after 90 days
Employee Referral Bonus
Employee Discount Program
Employee Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10,001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (173)
2022 (314)
2021 (349)
2020 (251)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-05-26
Company data provided by crunchbase
