Quality Scientist

Detroit, MI - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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.

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.

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.
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.

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

Required Experience:

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble 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 o...

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Job Description

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.

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.
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.

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

Required Experience:

Key Skills

Laboratory Experience
Immunoassays
Machine Learning
Biochemistry
Assays
Research Experience
Spectroscopy
Research & Development
cGMP
Cell Culture
Molecular Biology
Data Analysis Skills

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About Company

Thermo Fisher Scientific

Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more

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