Quality Scientist

Work Schedule
:
Standard (Mon-Fri)

Environmental Conditions
:
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description
:
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.

• 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.

• 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.
• 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.
• Working knowledge of ISO 13485:2016, FDA cGMP regulations, and associated quality system expectations.
• Experience with batch record reviews and electronic Quality Management systems.

• 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.