GCP QA Auditor – Radiopharmaceuticals & Clinical Trials
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Job Location:
Paramus, NJ - USA
Hourly Salary:
$ 55 - 60
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: GCP Quality Assurance Auditor Radiopharmaceuticals Northern NJ
Location: Northern New Jersey (Hybrid: 3 days onsite 2 days remote)
Job Description:
We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance drives quality management initiatives and conducts internal and external audits across clinical trials safety/pharmacovigilance and vendor operations (CROs CMOs investigator sites).
The ideal candidate has extensive GCP experience a strong pharmaceutical QA background and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel.
Key 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
Qualifications:
- Bachelors 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
Why Join Us:
- Be part of a fast-growing biopharma company making a difference in neurology and psychiatry
- Hybrid work schedule with flexible hours
- Opportunity for extension or full-time role
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
