Work Schedule

Other

Environmental Conditions

Office

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 product used in critical Biopharmaceutical applications. With your exceptional skills and expertise, you will contribute to the validation of laboratory analytical and physical test methods, enabling us to maintain our high standards.

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.

Requirements:

• 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.

• Familiarity with standard analytical methods such as HPLC, FTIR, TLC, and ICP-MS is desired.

• Understanding of ISO 13485:2016 standards and FDA cGMP regulations.

• Experience with batch record reviews and electronic Quality Management systems.

In addition to the exciting responsibilities and requirements, Thermo Fisher Scientific Inc. offers a wide range of benefits and career advancement opportunities. We value our employees and provide:

• 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.