QA Specialist

About the Role

This role is fully onsite, based at our Global Central Laboratory in Highland Heights, KY. 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.

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

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

Qualifications

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