New · posted Nov 6
Thermo Fisher Scientific · Biotechnology
Quality Specialist II
- Detroit, MI
- On-site
- Full-time
- Associate & Specialist
The role
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.
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.
What you need
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.
What you'll do
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.
Pay and benefits
Thermo Fisher Scientific didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
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.
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.
Where you'll work
Detroit, MIOn-siteOpen in Maps (opens in a new tab)
More jobs in Detroit, MISchedule and working conditions
Days
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.)
Division: Biologicals and Chemicals Division
From the posting
About Thermo Fisher
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.
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
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $81,125 | $85,250 | $94,750 |
Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 94 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs11
- Lab testing and methods10
- Collaboration and leadership8
- GMP and compliance4
- Quality systems and risk4
- Data and digital systems2
- Investigations and CAPA1
- Validation and qualification1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 116
- Open roles
- 116
- Distinct roles
- 50
- Locations
By discipline
- Quality73 61%
- Clinical41 34%
- Regulatory6 5%
By level
- Senior & Principal50 42%
- Associate & Specialist38 32%
- Manager26 22%
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Quality Specialist II at Thermo Fisher
Open until filled.