GCP Quality Assurance Auditor

Pay rate - $60/hr is the max pay rate

Total position:1

Relocation assistance:

No

Visa sponsorship eligibility:

No

• 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

• 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.

• 5+ years of pharmaceutical experience
• 2+ years of Radio Pharmaceutical 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

• Bachelor’s degree in a scientific, health care, or related discipline.
• Minimum 5+ years of experience in the
  pharmaceutical industry.
• Minimum 2 years of experience in Radiopharmaceuticals.
• Minimum 2 years of experience in Quality Assurance.
• Extensive
  
  GCP experience
  .
• Proven experience conducting and managing internal and external GXP audits, including clinical development and safety/pharmacovigilance audits.
• GCP guidelines and global regulatory requirements (e.g., FDA, EMA, ICH GCP).
• Clinical systems such as IRT and EDC from an audit perspective.
• Familiarity with Quality Management Systems (QMS), SOPs, and compliance documentation.

• 3 days onsite and 2 days remote (onsite Tuesday, Wednesday, and Thursday, each week). The hours can be flexible, between 7:30am and 5pm (8 hour shift).
• 10% travel is listed on the job description. However, it is not likely to occur, and if it does, it will be domestic travel only.
• This position is now open for 6 months, and there is potential to extend and/or go full time if they’re the right fit for the business.