Quality Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Quality Specialist II

Division: Biologicals and Chemicals Division

Location: Detroit, Michigan (On-site) - This position does not offer relocation assistance.

Work Authorization: Thermo Fisher Scientific is unable to provide employment visa sponsorship for this position, now or in the future.

Make an Impact. Build Your Career. Help Advance Science.

At Thermo Fisher Scientific, your work makes a difference. Every day, our colleagues come together to fulfill our Mission: enabling our customers to make the world healthier, cleaner and safer.

We're looking for a motivated, detail-oriented Quality Specialist II to join our team in Detroit, Michigan. This is an exciting opportunity for someone who enjoys hands-on laboratory work, solving problems, and collaborating with others to ensure the quality of products that support scientific innovation around the world.

About Our Detroit Team

Our Detroit site is part of Thermo Fisher Scientific's Biologicals and Chemicals Division, manufacturing peptones and specialty chemicals used in bioproduction and culture media applications. Operating under an ISO 13485-certified Quality Management System, our team plays an important role in maintaining the quality and reliability of products our customers depend on.

Discover Impactful Work

In this role, you'll be an important part of our Detroit Quality team, helping ensure our products meet established quality standards and are ready for customers when they need them.

You'll enjoy a combination of hands-on laboratory testing, quality documentation, problem-solving, and cross-functional collaboration. No two days will look exactly the same, giving you the opportunity to broaden your skills and gain exposure to multiple aspects of quality in a manufacturing environment.

A Day in the Life

Quality Assurance & Compliance

• Help maintain and continuously improve our ISO 13485:2016 Quality Management System.
• Review manufacturing batch records, equipment documentation, calibration records, and other quality-related documentation to ensure accuracy and compliance.
• Support timely product release by reviewing test results, completing lot release activities, and preparing Certificates of Analysis.
• Partner with internal teams to respond to customer quality and compliance inquiries, including regulatory documentation and supplier questionnaires.
• Coordinate document changes and updates to help keep our quality systems accurate, compliant, and efficient.
• Participate in validation activities, including protocol execution and documentation.
• Create and update standard operating procedures (SOPs) and other quality documents.
• Support internal and external audits, helping identify opportunities to strengthen our processes.

Hands-On Laboratory Testing & Quality Control

• Perform chemical and biological testing on raw materials and finished products to verify they meet quality specifications.
• Conduct a variety of laboratory tests, including pH, bioburden, loss on drying, growth promotion, titration, appearance testing, and other analytical methods.
• Set up, operate, and maintain laboratory equipment according to established procedures.
• Accurately document, review, and communicate laboratory results to support quality decisions and timely product release.
• Perform environmental monitoring, analyze trends, and report findings to support manufacturing operations.
• Help maintain laboratory readiness by coordinating supplies, equipment needs, and external laboratory services.

Collaboration & Continuous Improvement

• Work closely with colleagues across Quality, Manufacturing, and other departments to solve problems and support business priorities.
• Identify opportunities to improve processes, strengthen compliance, and support operational efficiency.
• Contribute to projects and initiatives that help our Detroit site continue delivering high-quality products to customers.

Keys to Success:

Education

• Bachelor's degree required (a degree in Biology, Chemistry, Biochemistry, or a related scientific discipline is preferred.)

Experience

• At least 1 year of experience in a Quality Control laboratory and/or Quality Assurance role required
• Experience within the pharmaceutical, biotechnology, or life sciences industry preferred.
• Experience with quality management systems, laboratory testing, or regulated manufacturing environments is valuable.
• Familiarity with ERP systems, electronic document control, CAPA, or training management software is a plus.

Skills & Attributes

• Strong attention to detail and a commitment to accuracy and quality.
• Good problem-solving and critical-thinking skills.
• Ability to organize priorities and manage multiple responsibilities in a fast-paced environment.

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