GCP Quality Assurance Auditor

Paramus, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: GCP Quality Assurance Auditor

Location: Paramus NJ (Hybrid)

Experience level: Mid-senior

Experience required: 5 Years

Education level: Bachelors degree

Job function: Accounting/Auditing

Industry: Pharmaceuticals

Total position: 1

Relocation assistance: No

Job description:

The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs CMOs investigator sites and all relevant vendors to support clinical trials.
The Auditor of Quality Assurance will work with the QA and cross functional teams communicate with QA consultants and has contact with external auditees vendors partners and affiliates. The ideal candidate will have extensive GCP experience.
This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance

Responsibilities:

Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
Plan and conduct audits of specific clinical processes based on risk.
Perform clinical vendor audits along with various SMEs (IRT EDC etc.) to comprehensively assess all services provided by a vendor.
Develop audit reports and distribute them to appropriate stakeholders.
Own and manage related clinical vendor non-conformances.
Review understand and audit clinical related regulations and guidelines (e.g. FDA regs GCP etc.).
Collaborate with clinical sourcing supplier quality and clinical partnership to manage clinical vendors.
Support the preparation coordination and participation of regulatory agency inspections.
Participate in and support quality improvement projects.

Qualifications:

5 years of pharmaceutical experience
2 years of RadioPharmaceutical and Quality Assurance experience
BS degree in scientific health care or related discipline
Intensive GCP and safety background
Experience with both internal and external process and systems audits
Strong knowledge of development policies procedures and standards (SOPs QMS)
Ability to work with global clinical teams in developing objectives for audits of clinical studies
10% Traveling required

Job Title: GCP Quality Assurance Auditor Location: Paramus NJ (Hybrid) Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Total position: 1 Relocation assistance: No Job description: Th...