Life Science Jobs at Thermo Fisher Scientific
Thermo Fisher Scientific is hiring a Quality Specialist II in St. Louis, Missouri, offering an excellent opportunity for quality professionals to work at the forefront of pharmaceutical and biotech manufacturing. This is a fully on-site role. The Life Science Jobs at Thermo Fisher are ideal for candidates with experience in GMP compliance, FDA regulations, quality systems, and continuous improvement, who are driven by the mission to make the world healthier, cleaner, and safer.
Job Details:
- Job Title: Quality Specialist II
- Job ID: R-01338771
- Category: Quality & Regulatory
- Location: St. Louis, Missouri, USA
- Work Type: Full-Time
- Work Mode: Fully Onsite
- Schedule: Standard (Monday–Friday)
- Travel: Up to 10%
About Thermo Fisher Scientific:
Thermo Fisher Scientific is a global leader in scientific services, life sciences, diagnostics, and biopharma manufacturing, supporting customers in advancing healthcare, protecting the environment, and ensuring food safety. With a strong culture of integrity, quality, and innovation, Thermo Fisher empowers professionals to grow their careers while contributing to solutions that improve lives worldwide.
Educational Qualifications for the Quality Specialist Role:
- Advanced degree (Master’s or higher) with no prior experience OR
- Bachelor’s degree with 2+ years of experience in a GMP-regulated environment
- Preferred disciplines: Biology, Life Sciences, or related fields
Key Responsibilities:
- Ensure compliance with cGMP standards, FDA regulations, and international quality requirements in this Quality Specialist Role.
- Support manufacturing operations across multiple product lines
- Maintain and improve Quality Management Systems (QMS)
- Lead and support deviation investigations, CAPA, change control, and root cause analysis in the Life Science Jobs at Thermo Fisher Scientific.
- Conduct internal audits and support external regulatory inspections
- Prepare, review, and manage quality documentation and technical reports
- Collaborate with cross-functional teams to drive continuous improvement initiatives
- Ensure adherence to cleanroom and gowning procedures where required
- Support shift-based manufacturing operations as needed
Skills & Experience Required for the Quality Specialist Role:
- Strong knowledge of cGMP, FDA, and ISO 9001 / ISO 13485 standards
- Hands-on experience with quality systems such as TrackWise, MasterControl, or equivalent is required for the Quality Specialist Role.
- Experience in audit readiness and regulatory inspection support
- Excellent technical writing and documentation skills
- Strong analytical, investigative, and problem-solving abilities
- Proficiency in Microsoft Office Suite and quality software systems
- Ability to work independently as well as in cross-functional teams
- Project management and organizational skills
- Ability to work in controlled environments and meet physical job requirements
Work Environment & Physical Requirements:
- GMP-compliant manufacturing and office settings
- Standing and walking for extended periods
- Occasional lifting up to 25 lbs
- Compliance with safety, gowning, and cleanroom protocols
Why Join Thermo Fisher Scientific?
At Thermo Fisher, quality is more than compliance—it’s a commitment to doing it right the first time. You’ll collaborate with global teams, gain exposure to world-class manufacturing operations, and play a critical role in delivering safe, effective products that make a real impact on global health and scientific progress.
