QA Specialist Thermo Fisher Scientific - 3.4 Highland Heights, KY Job Details Full-time 10 hours ago Qualifications Investigations regulatory compliance Defect resolution root cause analysis Preventive action implementation Good documentation practices (GDP) Quality control preventive actions Corrective and preventive actions (CAPA) Regulatory/legal compliance standards in production Root cause analysis Cross-functional collaboration Quality control records management Cross-functional communication Laboratory compliance and regulatory documentation Quality assurance experience within healthcare Full Job Description Work Schedule Standard (Mon-Fri) Environmental Conditions Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description 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.

What You'll Do:

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

REQUIREMENTS

Education and Experience:

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

Required Knowledge, Skills, and Abilities:

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

Work Environment:

Onsite position located in Highland Heights, KY Office and laboratory environment supporting Global Central Laboratories Frequent collaboration with laboratory operations and quality teams Regular participation in internal audits and inspection readiness activities Why join us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.