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Temporary Assignment Duration: 6+ Months Work Type: Onsite Shift: Mon-Fri 9.00 AM-5.00 PM * The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. * This ...

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GCP Auditor, Quality Assurance

GCP Auditor, Quality Assurance

Merican

Paramus, NJ • On-site

Other

Posted 22 days ago


Job description

Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: GCP Auditor, Quality Assurance
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 6+ Months
Work Type: Onsite
Shift: Mon-Fri 9.00 AM-5.00 PM
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 Company's 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

Requirements:
  • 2+ years of pharmaceutical 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

TASKS AND RESPOSIBILITIES:
  • 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.
  • Candidates MUST HAVE 2+ years of radiopharmaceuticals and quality experience.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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About Merican

Sourced by ZipRecruiter

Merican is a IT Service consulting firm, specialized in Digital adoption and Business automation. With our diverse collection of skilled and committed consultants, technology companies, businesses and digital experts, we provide our subject expertise and our unique client service approach, a best-in-class global model of delivery suited to the business demands of our clients. We ensure that we implement future-oriented solutions for our clients via investments in people, solutions, technologies, competencies and infrastructure.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Columbia , MD, US

Year founded

2020

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