Gxp Auditor
Union City, CA ยท On-site
About the job Gxp Auditor GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of ...
Union City, CA ยท On-site
About the job Gxp Auditor GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of ...
Union City, CA ยท On-site
About the job Gxp Auditor GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of ...
Waltham, MA ยท On-site
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
Waltham, MA ยท On-site
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
Norwood, MA ยท On-site
We are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and management of Digital Quality Automation Systems and laboratory instrumentation within GMP ...
Norwood, MA ยท On-site
We are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and management of Digital Quality Automation Systems and laboratory instrumentation within GMP ...
Direct experience with automation solutions such as Hamilton Venus preferred Experience with Linux Ubuntu SUDO commands a plus Experience with GAMP and GxP compliance regulations Experience in ...
New
Direct experience with automation solutions such as Hamilton Venus preferred Experience with Linux Ubuntu SUDO commands a plus Experience with GAMP and GxP compliance regulations Experience in ...
New
Cambridge, MA ยท On-site
$138K - $182K/yr
As a Senior GxP Product Manager, Digital, you will lead system engineering initiatives and manage multiple digital platforms and applications that align with Moderna's clinical and regulatory digital ...
Cambridge, MA ยท On-site
$138K - $182K/yr
As a Senior GxP Product Manager, Digital, you will lead system engineering initiatives and manage multiple digital platforms and applications that align with Moderna's clinical and regulatory digital ...
The Role The GxP Endpoint Engineer will serve as the primary owner of the SCCM environment supporting Moderna's GxP operations, ensuring all configurations, deployments, and processes align with ...
The Role The GxP Endpoint Engineer will serve as the primary owner of the SCCM environment supporting Moderna's GxP operations, ensuring all configurations, deployments, and processes align with ...
Boca Raton, FL ยท On-site
$45 - $61.50/hr
GxP Test Lead Location: Boca Raton, Florida, USA Primary & Secondary Skill : GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain JD: * 15+ years of software QA/testing ...
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Boca Raton, FL ยท On-site
$45 - $61.50/hr
GxP Test Lead Location: Boca Raton, Florida, USA Primary & Secondary Skill : GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain JD: * 15+ years of software QA/testing ...
$138K - $182K/yr
As a Senior GxP Product Manager, Digital, you will lead system engineering initiatives and manage multiple digital platforms and applications that align with Moderna's clinical and regulatory digital ...
$138K - $182K/yr
As a Senior GxP Product Manager, Digital, you will lead system engineering initiatives and manage multiple digital platforms and applications that align with Moderna's clinical and regulatory digital ...
Norwood, MA ยท On-site
$121K - $194K/yr
Title : Sr. Engineer, GxP Systems Reports to : Director, Product Management Function : Digital Location : Norwood, MA The Role: ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood ...
Norwood, MA ยท On-site
$121K - $194K/yr
Title : Sr. Engineer, GxP Systems Reports to : Director, Product Management Function : Digital Location : Norwood, MA The Role: ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood ...
The Role The GxP Endpoint Engineer will serve as the primary owner of the SCCM environment supporting Moderna's GxP operations, ensuring all configurations, deployments, and processes align with ...
The Role The GxP Endpoint Engineer will serve as the primary owner of the SCCM environment supporting Moderna's GxP operations, ensuring all configurations, deployments, and processes align with ...
Cambridge, MA ยท On-site
$139K - $184K/yr
As a Senior GxP Product Manager, you will lead system engineering initiatives and manage digital platforms to deliver validated lab informatics solutions, collaborating with various teams to ensure ...
Cambridge, MA ยท On-site
$139K - $184K/yr
As a Senior GxP Product Manager, you will lead system engineering initiatives and manage digital platforms to deliver validated lab informatics solutions, collaborating with various teams to ensure ...
San Diego, CA ยท On-site
$50 - $60/hr
The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. * In this on-site contracted role, you will lead the enhancement and maintenance of local ...
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San Diego, CA ยท On-site
$50 - $60/hr
The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. * In this on-site contracted role, you will lead the enhancement and maintenance of local ...
Norwood, MA ยท On-site
$121K - $194K/yr
Title : Sr. Engineer, GxP Systems Reports to : Director, Product Management Function : Digital Location : Norwood, MA The Role: ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood ...
Norwood, MA ยท On-site
$121K - $194K/yr
Title : Sr. Engineer, GxP Systems Reports to : Director, Product Management Function : Digital Location : Norwood, MA The Role: ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood ...
Chicago, IL ยท On-site
GXP-Validation Analyst; Location: Chicago/Nearshore CST time PURPOSE OF THE POSITION * Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing procedures * Performing ...
Chicago, IL ยท On-site
GXP-Validation Analyst; Location: Chicago/Nearshore CST time PURPOSE OF THE POSITION * Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing procedures * Performing ...
Position Summary The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories ...
Position Summary The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories ...
The Position The GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP ...
The Position The GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP ...
The Position The GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP ...
Quick apply
The Position The GxP Laboratory Systems Administrator position is responsible for supporting the development and delivery of various laboratory systems including daily system administration of GxP ...
Waltham, MA ยท On-site
$122K - $150K/yr
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
Waltham, MA ยท On-site
$122K - $150K/yr
The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP ...
Chicago, IL ยท On-site
$161K/yr
Audit & Monitoring Cornerstone On Demand LMS FDA 21 CFR GxP Assessment Data Analytics Top skills required for this role: 1. Facilitate audit request process for GxP regulatory inspections, customer ...
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Chicago, IL ยท On-site
$161K/yr
Audit & Monitoring Cornerstone On Demand LMS FDA 21 CFR GxP Assessment Data Analytics Top skills required for this role: 1. Facilitate audit request process for GxP regulatory inspections, customer ...
Position Summary The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories ...
Position Summary The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories ...
$10.10 - $11.06
4% of jobs
$11.06 - $12.02
7% of jobs
$12.02 - $12.98
12% of jobs
$13.05 is the 25th percentile. Wages below this are outliers.
$12.98 - $13.94
23% of jobs
The median wage is $14.07 / hr.
$13.94 - $14.90
24% of jobs
$15.18 is the 75th percentile. Wages above this are outliers.
$14.90 - $15.87
13% of jobs
$15.87 - $16.83
2% of jobs
$16.83 - $17.79
2% of jobs
$17.79 - $18.75
9% of jobs
$18.75 - $19.71
3% of jobs
$19.71 - $20.67
0% of jobs
$10
$14
$20
| Aspect | Gxp | Quality Assurance Specialist |
|---|---|---|
| Required Credentials | Gxp compliance training, industry-specific certifications | Quality assurance certifications, such as CQE or CQA |
| Work Environment | Regulated industries like pharmaceuticals, biotech, and medical devices | Manufacturing, healthcare, or software industries |
| Employer & Industry Usage | Used in industries with strict regulatory standards | Common in quality-focused roles across various sectors |
| Comparison Search Intent | Understanding Gxp compliance roles | Comparing quality assurance roles with Gxp responsibilities |
Gxp professionals focus on ensuring compliance with Good Practice standards in regulated industries, while Quality Assurance Specialists oversee quality processes across various sectors. Both roles require quality-related certifications, but Gxp roles emphasize regulatory compliance specific to industries like pharmaceuticals and biotech. Understanding these differences helps job seekers identify the right career path based on industry and certification requirements.

About the job Gxp Auditor
GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of RxCloud. This position will also act as a Subject Matter Expert (SME) for GxP auditing and quality projects. It will be responsible for supporting the ongoing development and management of the Quality Management Auditing system. This position is responsible for independently managing quality/GxP auditing deliverables scheduled.
Responsibilities Include
โข Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
โข Develop and implement the global audit strategy, aligning with organizational goals and regulatory requirements.
โข Perform audits across various departments and functional areas.
โข Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.
โข Review and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes.
โข Collaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved.
โข Conduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues.
โข Prepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders.
โข Responsible for leading, conducting, and documenting investigations relating to audit findings noted internally.
โข Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings.
โข Ensure audits are performed within budget and according to plan.
โข Facilitate post-audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings.
โข Produce draft and final versions of audit plans, reports, and summaries within defined timeframes and in accordance with internal policies/procedures.
โข Promote continual improvement regarding stakeholder satisfaction, emphasizing Quality/GxP auditing services.
โข Stay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.
Required Qualifications
โข Minimum bachelor's degree in any scientific discipline.
โข A minimum of 20 years of relevant experience including 15 years of GxP. auditing in a regulated environment focused on quality.
โข Excellent knowledge of GxP regulatory requirements.
โข Experience using electronic Quality Management Systems.
โข Ability to manage multiple projects in a fast-paced environment.
โข Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
โข Ability to understand when issues require escalation to Senior Quality Management.
โข Must be detail-oriented; must be precise and organized in the handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.
Sourced by ZipRecruiter
It services
1 - 10 Employees
Pleasanton, CA, US
2020