QA Specialist
About The Position
This role is fully onsite, based at our Global Central Laboratory in Highland Heights, KY. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. 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. At Thermo Fisher Scientific, you'll discover meaningful work that has a real impact on global health. As part of our Global Central Laboratories Quality team, you'll help ensure the quality systems that support clinical trial testing remain compliant, inspection-ready, and aligned with global regulatory standards. The Quality Assurance Specialist role focuses on quality systems, regulatory compliance, audits, and documentation review. Rather than performing laboratory testing, you'll work closely with laboratory and operational teams to verify that processes are executed correctly, documentation is complete and accurate, and quality requirements are consistently met. If you enjoy auditing processes, identifying compliance risks, reviewing regulated documentation, and driving continuous improvement in a GMP environment, this is an opportunity to make a meaningful impact while supporting customers developing tomorrow's therapies.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered
- 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
- Strong problem-solving skills with experience supporting quality investigations, root cause analysis, and CAPA (Corrective and Preventive Action) activities
- 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
Nice To Haves
- additional language skills are considered beneficial
Responsibilities
- Conduct routine internal quality audits and support client and regulatory inspections
- Review batch records, quality documentation, and regulated records for completeness, accuracy, and compliance
- 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
- Participate in risk assessments and identify opportunities to strengthen quality processes
- Provide guidance and training on quality processes and documentation practices when needed
- Collaborate with cross-functional teams to promote a culture of quality and continuous improvement
Benefits
- relocation assistance is not provided
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
