Black Star Technology, LLC · 1 day ago
GCP QA Auditor – Radiopharmaceuticals & Clinical Trials
Paramus, New Jersey, United States
Full-time
Hybrid
Senior Level
5+ years expBlack Star Technology, LLC is a rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. They are seeking an experienced GCP Quality Assurance Auditor to ensure GXP compliance, drive quality management initiatives, and conduct internal and external audits across clinical trials.
Staffing & Recruiting
Responsibilities
Plan and perform global clinical process and vendor audits across all clinical trials
Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems
Prepare detailed audit reports and manage related non-conformances
Ensure compliance with GCP, FDA, EMA, and ICH regulations
Support regulatory inspections and quality improvement initiatives
Collaborate with clinical teams, QA, and vendor management
Qualification
Required
Bachelor's degree in a scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA
Extensive GCP and safety/pharmacovigilance experience
Proven experience in internal and external GXP audits
Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation
Strong communication and cross-functional collaboration skills
Up to 10% domestic travel
Benefits
Hybrid work schedule with flexible hours
Opportunity for extension or full-time role
Company
Black Star Technology, LLC
Recruiting the right talent can be a challenging and time-consuming process for businesses.
Founded in 2022Rowland Heights, California, US
11-50 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase