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.
- Clear written and verbal communication skills, including the ability to prepare accurate technical documentation.
- Comfortable using Microsoft Office applications and learning new systems.
- A collaborative, team-oriented approach and willingness to support others.
- Self-motivation, initiative, and a desire to continuously learn and improve.
Why Join Our Team?
- Your work has purpose. Contribute to the quality of products used in scientific research, bioproduction, and other important life sciences applications.
- Build a versatile skill set. Gain valuable experience in both Quality Assurance and Quality Control, developing expertise that can support your long-term career growth.
- Make a visible impact. Be part of a site team where your contributions directly support product quality, manufacturing operations, and customer satisfaction.
- Learn and grow. Join a global organization that values professional development, continuous improvement, and opportunities to expand your capabilities.
- Be part of something bigger. Work alongside colleagues who share a commitment to integrity, innovation, involvement, and delivering results.
Our Benefits
At Thermo Fisher Scientific, we recognize that our colleagues are essential to our success. We offer competitive compensation, an annual incentive plan bonus, healthcare benefits, and a range of employee benefits designed to support our colleagues.
You'll also have access to career development opportunities within an innovative, forward-thinking global organization.
Start Your Story With Us
Ready to grow your career while making a meaningful difference?
Join our Detroit Quality team and help ensure the products we manufacture meet the standards our customers rely on.
Apply today: http://jobs.thermofisher.com
At Thermo Fisher Scientific, our Mission is to enable our customers to make the world healthier, cleaner and safer. Together, our global team of 100,000+ colleagues works to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.#StartYourStory
