Thermo Fisher Scientific
QA Specialist
Highland Heights, Kentucky, USA
No sponsorshipDetected 1 day ago
ComplianceAuditingGMPResearchCommunicationCollaborationProblem SolvingOrganizational SkillsGxP
About the role
- We welcome applicants from all locations within the US.
- At Thermo Fisher Scientific, you'll discover meaningful work that has a real impact on global health.
- The Quality Assurance Specialist role focuses on quality systems, regulatory compliance, audits, and documentation review.
Responsibilities
- Conduct routine internal quality audits and support client and regulatory inspections
- Partner with laboratory and operational teams to investigate quality events, perform root cause analysis, and support Corrective and Preventive Actions (CAPAs)
- Help maintain inspection readiness by ensuring quality systems comply with GMP (Good Manufacturing Practice) and applicable regulatory requirements
- Collaborate with cross-functional teams to promote a culture of quality and continuous improvement
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Required Knowledge, Skills, and Abilities:
- Fluency in English required
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Skills
- Experience working within a regulated Quality Assurance or Quality Systems environment
- Working knowledge of GMP (Good Manufacturing Practice), GxP (Good Practice), or comparable quality regulations
- Experience conducting or supporting internal quality audits, regulatory inspections, or supplier/vendor audits
- Experience reviewing regulated documentation, quality records, batch records, or controlled documentation
- Excellent written and verbal communication skills
- Strong organizational skills with exceptional attention to detail
- Ability to prioritize multiple assignments while maintaining high quality standards
- Experience collaborating across functional teams to improve quality and compliance
- Fluency in English required; additional language skills are considered beneficial
Benefits
- Education and Experience:
- In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered
Company info
- When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
- Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Visa & Work Authorization
- Must be legally authorized to work in the United States without sponsorship.
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This listing is sourced directly from Thermo Fisher Scientific's careers page and normalized into a canonical job model.