Demo

Sr. GCP Quality Assurance Auditor

Suna Solutions
Paramus, NJ Contractor
POSTED ON 4/18/2025
AVAILABLE BEFORE 5/17/2025

๐Ÿšจ NOW HIRING: Sr. GCP Quality Assurance Auditor

๐Ÿ“ Location: Hybrid โ€“ Paramus, NJ (3 Days Onsite: Tue, Wed, Thurs)

๐Ÿ’ต Pay Rate: $45โ€“$50/hr (W2)

๐Ÿ•˜ Hours: 9:00 AM โ€“ 5:00 PM

๐Ÿ“† Duration: 5โ€“6 Month Contract

๐Ÿ’Š Industry: Biopharmaceutical โ€“ Neurology & Psychiatry


Why You Should Join Us:

Be a key player at a rapidly growing biopharma company making waves in Neurology and Psychiatry therapies. This is your chance to make an impact, ensure regulatory compliance, and collaborate with top-tier clinical teams.

What Youโ€™ll Be Doing:


As a Sr. GCP QA Auditor, youโ€™ll ensure GXP compliance and support quality systems across internal teams and external partners. Youโ€™ll report directly to the Director of GCP/PVG Quality Assurance and help guide the company through internal and external audits, vendor oversight, and regulatory inspections.


๐Ÿ” Core Responsibilities:

  • Lead and conduct global clinical audits (internal & vendor-based)
  • Assess compliance with FDA regulations, GCP guidelines, and internal SOPs
  • Write audit reports, manage non-conformances, and support CAPAs
  • Collaborate with cross-functional teams: Clinical Ops, PVG, CMO, CRO
  • Prepare for and support regulatory inspections
  • Contribute to continuous quality improvement projects
  • Occasional travel (~10%) required


What You Bring to the Table:

โœ… 5 years in pharma with a strong GCP auditing background

โœ… BS in Science, Healthcare, or related field

โœ… Proven experience with clinical audits, systems audits, SOPs, and QMS

โœ… Strong communication skills and cross-functional collaboration experience

โœ… Ability to thrive in a dynamic, fast-paced environment

โœ… Flexibility for potential changes in hybrid schedule


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.

Salary : $45 - $50

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