Quality Specialist II jobs in United States
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Thermo Fisher Scientific · 9 hours ago

Quality Specialist II

Thermo Fisher Scientific is a global leader in healthcare and scientific advancement, committed to making the world healthier, cleaner, and safer. As a Quality Specialist II, you'll ensure compliance with quality standards and regulations while contributing to manufacturing operations and continuous improvement initiatives.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
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H1B Sponsor Likelynote

Responsibilities

Ensure compliance with GMP standards, FDA regulations, and international quality requirements
Support manufacturing operations across multiple product lines
Implement continuous improvement initiatives
Conduct investigations
Maintain quality management systems

Qualification

CGMP regulationsISO standardsQuality management systemsDeviation investigationsAnalytical skillsTechnical writingCommunication skillsProject managementOrganizational skillsCollaborative skills

Required

Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent)
Experience in deviation investigations, CAPA, change control, and root cause analysis
Proficient in Microsoft Office suite and quality management software systems
Technical writing and documentation skills
Analytical and problem-solving abilities
Clear verbal and written communication skills
Ability to work independently and collaboratively in cross-functional teams
Experience conducting internal audits and supporting external regulatory inspections
Project management and organizational skills
Ability to work in cleanroom environments and follow gowning procedures where required
Up to 10% travel may be required
Must be able to work various shifts to support manufacturing operations
Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs

Preferred

Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
Additional language skills may be beneficial

Company

Thermo Fisher Scientific

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Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)

Funding

Current Stage
Public Company
Total Funding
$15.97B
Key Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B

Leadership Team

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Stephen Williamson
Senior Vice President and Chief Financial Officer
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Daniella Cramp
Senior Vice President and President, Bioproduction Group
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Company data provided by crunchbase