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Gcp Qa Auditor Jobs (NOW HIRING)

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 * The GCP Quality Assurance Auditor ...

Quality Assurance Auditor II - hybrid ICON is a global healthcare intelligence and clinical ... Experience with, with ICH-GCP and with relevant GxP regulations and guidelines. * BSc Degree is ...

Quality Assurance Auditor II - hybrid ICON is a global healthcare intelligence and clinical ... Experience with, with ICH-GCP and with relevant GxP regulations and guidelines. * BSc Degree is ...

Quality Assurance Auditor Hubot - Tri Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is ...

The Quality Assurance (QA) Auditor is responsible for evaluating the accuracy, completeness, and compliance of Patient Access workflows to support highquality registration practices and reduce ...

Quality Assurance Auditor Hubot - Tri Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is ...

$24 - $27/hr

Overview The Quality Assurance Auditor will perform monitoring, oversight, and quality assurance reviews/audits of all lines of business as defined by CMS, NYS DOH, NYS DFS and any/all policies and ...

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Gcp Qa Auditor information

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How much do gcp qa auditor jobs pay per hour?

As of Jul 30, 2026, the average hourly pay for gcp qa auditor in the United States is $31.24, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $36.54 per hour, depending on experience, location, and employer.

What is the difference between Gcp Qa Auditor vs Gcp Cloud Security Engineer?

AspectGcp Qa AuditorGcp Cloud Security Engineer
CertificationsGCP certifications, QA-related credentialsGCP certifications, security certifications (e.g., CISSP)
Work EnvironmentQuality assurance teams, testing environmentsSecurity teams, cloud infrastructure environments
Employer & IndustryTech companies, cloud service providersTech companies, cybersecurity firms, cloud providers
Primary FocusTesting GCP applications for quality and complianceSecuring GCP cloud infrastructure and data

The Gcp Qa Auditor primarily focuses on testing and ensuring the quality of GCP applications, while the Gcp Cloud Security Engineer concentrates on securing cloud infrastructure. Both roles require GCP knowledge but differ in their core responsibilities and certifications.

What are some common challenges GCP QA Auditors face when conducting audits across multiple clinical trial sites?

GCP QA Auditors frequently encounter challenges such as varying levels of regulatory compliance across sites, differences in documentation practices, and resistance to change from site personnel. Effective communication, adaptability, and a thorough understanding of both global and local GCP regulations are essential to navigate these issues. Building strong relationships with site teams and fostering a collaborative approach can help ensure a successful audit process and continuous improvement in clinical trial quality.

What is a GCP QA Auditor?

A GCP QA Auditor is a professional responsible for evaluating and ensuring compliance with Good Clinical Practice (GCP) guidelines in clinical research settings. Their main role is to conduct audits of clinical trials, study sites, and related processes to verify that all activities adhere to regulatory requirements and ethical standards. GCP QA Auditors help identify potential risks, recommend corrective actions, and ensure the integrity of data collected during clinical studies. They also provide guidance and training to research staff on maintaining GCP compliance.

What are the key skills and qualifications needed to thrive as a GCP QA Auditor, and why are they important?

To thrive as a GCP QA Auditor, you need in-depth knowledge of Good Clinical Practice (GCP) guidelines, regulatory requirements, and experience in clinical research or quality assurance, often supported by a relevant science degree. Familiarity with auditing tools, electronic quality management systems (eQMS), and certifications such as RQA or ASQ are commonly required. Strong attention to detail, critical thinking, effective communication, and the ability to work independently are essential soft skills. These competencies ensure compliance, data integrity, and the protection of human subjects in clinical trials.
What states have the most Gcp Qa Auditor jobs? States with the most job openings for Gcp Qa Auditor jobs include:
Infographic showing various Gcp Qa Auditor job openings in the United States as of July 2026, with employment types broken down into 89% Full Time, 8% Part Time, 2% Contract, and 1% Nights. Highlights an 87% Physical, 6% Hybrid, and 7% Remote job distribution, with an average salary of $64,986 per year, or $31.2 per hour.

GCP Auditor, Quality Assurance

Merican

Paramus, NJ โ€ข On-site

Other

Re-posted 27 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.

TekWissenยฎ 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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