GCP Quality Assurance Auditor

Now Hiring: GCP Quality Assurance Auditor/GCP Auditor

Location: Onsite – Paramus, New Jersey, 07652

Contract Length: 11 weeks

Pay Rate: $50–$60/hr (W2)

Schedule: Monday to Friday | 9:00 AM – 5:00 PM

About the Role

We are seeking a highly motivated GCP Quality Assurance Auditor to join our growing biopharmaceutical team focused on Neurology and Psychiatry therapies. Reporting to the Director of GCP/PVG Quality Assurance, you will play a key role in ensuring GXP compliance, implementing compliance initiatives, and supporting quality management systems across clinical operations, non-clinical, and manufacturing.

This position involves conducting both internal and external GXP audits, managing relationships with CROs, CMOs, investigator sites, and vendors, and supporting the organization in maintaining the highest quality standards. This is an onsite position in Northern New Jersey.

Key Responsibilities

• Plan and conduct scheduled global clinical process and vendor audits across all clinical trials.
• Conduct risk-based audits of specific clinical processes.
• Perform clinical vendor audits alongside SMEs (e.g., IRT, EDC) to evaluate vendor services.
• Prepare audit reports and distribute to relevant stakeholders.
• Manage vendor non-conformances and follow up on corrective actions.
• Review and apply clinical regulations and guidelines (FDA regulations, GCP, etc.).
• Collaborate with clinical sourcing, supplier quality, and clinical teams to manage vendor performance.
• Support regulatory inspections and participate in quality improvement projects.

Qualifications

• Must have 2 years of experience in radiopharmaceuticals and quality assurance.
• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Extensive knowledge of GCP and safety standards.
• Experience conducting internal and external process and system audits.
• Strong understanding of development policies, procedures, and SOPs/QMS.
• Ability to work with global clinical teams to define audit objectives.
• Willingness to travel up to 10%.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.