Quality Assurance (QA) Specialist – Clinical Research
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Job Description
The Quality Assurance Specialist ensures that clinical trials, systems, and processes comply with regulatory requirements, ICH-GCP guidelines, and internal SOPs. This role supports audit readiness, quality oversight, and continuous improvement initiatives.
Job Responsibilities
Key Job Responsibilities
Conduct GCP audits of sites, vendors, and internal processes
Review and maintain SOPs, policies, and quality documentation
Support CAPA development, implementation, and tracking
Ensure inspection readiness for regulatory authorities
Identify quality risks and recommend mitigation strategies
Provide GCP training and quality guidance to teams
Support vendor qualification and oversight
Skills + Experience
Required Skills & Competencies
Strong knowledge of ICH-GCP, FDA regulations, and quality systems
Experience with audits, inspections, and CAPA management
Strong analytical, documentation, and communication skills
Attention to detail and independent judgment
Required Experience & Qualifications
Bachelor’s degree in Life Sciences or related field
3–5+ years of QA or compliance experience in clinical research
Experience in CRO, sponsor, or regulated environments
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JOB CATEGORY
Life Science
LOCATION
Remote Position
JOB TYPE
Full Time
EXPERIENCE LEVEL
Mid Level
SALARY
$95k - $130k
REFERENCE NUMBER
#222812244
About Us
At Renclave, our approach is built on clarity, expertise, and long-term relationships. We understand that career moves and hiring decisions are significant, which is why we focus on delivering a disciplined, transparent experience from start to finish.
When you work with Renclave, you can expect:
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Industry-informed guidance from recruiters who understand regulated and technical environments
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Confidentiality and discretion throughout the recruitment process
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Opportunities aligned with your experience, goals, and market value
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Clear communication at every stage—no uncertainty or unnecessary delays
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Professional advocacy, whether you are a candidate or a hiring partner
Our goal is not to place quickly—it is to place correctly.