Zachary Piper Solutions
Posted 11 days agoVerified live 2d ago
GCP Quality Assurance Specialist
Brief overview
Remote
UndergradOr in progress
$80k–$120k/yrStated range
3+ yrsMinimum
Clinical Research Quality AssuranceGCP Clinical Site AuditingRegulatory Agency AuditsCRO Quality SystemsClinical Practice (GCP) RegulationsMicrosoft Office
About the company
Zachary Piper Solutionszacharypiper.com
Zachary Piper Solutions is an IT company providing government contracting solutions in support of the nation’s Intelligence Community.
Job description
Summary
Piper Companies is seeking a GCP Quality Assurance Specialist to support regulated clinical research programs for a leading clinical research organization. The role focuses on maintaining the Quality Management System, conducting GCP audits, administering quality programs, tracking quality metrics, and supporting regulatory inspections and audit readiness.
Responsibilities
- Support the maintenance and continuous improvement of the Quality Management System (QMS)
- Administer QA training, document control, CAPA, and customer complaint programs
- Conduct and support GCP audits of clinical sites, vendors, and suppliers
- Perform internal audits and track quality metrics for continual improvement initiatives
- Manage QA-controlled document review cycles to ensure procedural compliance
- Collaborate with clinical research stakeholders to maintain GCP compliance
- Support regulatory authority inspections and audit readiness activities
Skills
- 3–5+ years of Quality Assurance experience within clinical research environments
- Strong hands-on experience conducting GCP clinical site audits (internal and external)
- Experience supporting regulatory agency audits and CRO quality systems
- Knowledge of current Good Clinical Practice (GCP) regulations and compliance requirements
- Excellent written and verbal communication skills with proficiency in Microsoft Office
- Bachelor's degree required
Qualifications
Must Haves
- 3–5+ years of Quality Assurance experience within clinical research environments
- Strong hands-on experience conducting GCP clinical site audits (internal and external)
- Experience supporting regulatory agency audits and CRO quality systems
- Knowledge of current Good Clinical Practice (GCP) regulations and compliance requirements
- Excellent written and verbal communication skills with proficiency in Microsoft Office
- Bachelor's degree required
Benefits
- PTO
- Paid Holidays
- Medical
- Dental
- Vision
- 401K
- Tuition Reimbursement
- Paid Maternity Leave
- Military Reserve Pay Offset
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