GCP Auditor, Quality Assurance

Company: Tek Wissen LLC

GCP Auditor, Quality Assurance

GCP Auditor – Quality Assurance

Paramus, New Jersey, USA

Temporary Assignment – 2 Months

Onsite

Mon‑Fri 9:00 AM – 5:00 PM

The GCP Quality Assurance Auditor will report to the Director of GCP/PGV Quality Assurance. This position focuses 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 audits.

The role also provides day‑to‑day support to the GCP QA Director in clinical operations, non‑clinical, and manufacturing functions to manage CROs, CMOs, investigator sites, and all relevant vendors supporting clinical trials.

• We are a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.
• Our headquarters are in Northern New Jersey and require on‑site presence.
• Admission of all types of audits in the Clinical Development and Safety Pharmacovigilance audit program.

• 2+ years of pharmaceutical experience.
• BS degree in a 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 audit objectives for clinical studies.
• 10% travel required.
• Must have 2 years of radiopharmaceuticals and quality experience.

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

• Laboratory Experience
• Quality Assurance
• FDA Regulations
• ISO 9001
• Quality Audits
• Quality Management
• GLP
• cGMP
• EPA
• QA/QC
• Toxicology Experience
• Aviation Experience

Tek Wissen Group is an equal opportunity employer supporting workforce diversity.

Employment Type: Full Time

Experience

Required:

Years

Vacancy: 1