Suna Solutions ยท 1 day ago
GCP Quality Assurance Auditor
Paramus, NJ
Contract
Onsite
Entry, Mid Level
$50/hr - $60/hr
2+ years expSuna Solutions is a growing biopharmaceutical company focused on Neurology and Psychiatry therapies, seeking a GCP Quality Assurance Auditor. The role involves ensuring GXP compliance, conducting audits, and supporting quality management systems across various clinical operations.
DeliveryHuman ResourcesInformation Technology
Hiring Manager
Rajesh Kumar
Responsibilities
Plan and conduct scheduled global clinical process and vendor audits across all clinical trials
Conduct risk-based audits of specific clinical processes
Perform clinical vendor audits alongside SMEs (e.g., IRT, EDC) to evaluate vendor services
Prepare audit reports and distribute to relevant stakeholders
Manage vendor non-conformances and follow up on corrective actions
Review and apply clinical regulations and guidelines (FDA regulations, GCP, etc.)
Collaborate with clinical sourcing, supplier quality, and clinical teams to manage vendor performance
Support regulatory inspections and participate in quality improvement projects
Qualification
Required
Must have 2+ years of experience in radiopharmaceuticals and quality assurance
Bachelor's degree in a scientific, healthcare, or related discipline
Extensive knowledge of GCP and safety standards
Experience conducting internal and external process and system audits
Strong understanding of development policies, procedures, and SOPs/QMS
Ability to work with global clinical teams to define audit objectives
Willingness to travel up to 10%
Company
Suna Solutions
Suna Solutions is a staffing and recruiting company offering temporary staffing services.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase