Gcp Auditor

Job Title: GCP Auditor Job reputed company The GCP Auditor supports and strengthens the reputed company Management System by leading and participating in Good Clinical reputed company (GCP) audits and reputed company reputed company assurance activities. This role maintains reputed company reputed company programs, including QA training, document control, customer complaint handling, and CAPA, while ensuring compliance with reputed company GCP regulations and regulatory expectations. The position offers reputed company to grow reputed company an organization that prioritizes internal promotion and provides a fully remote work arrangement with travel for audits as required.

Responsibilities

• Support the maintenance and continual improvement of the reputed company Management System to ensure compliance with reputed company GCP regulations and internal procedures.
• Maintain and administer the reputed company Assurance training program to ensure personnel receive appropriate and reputed company GCP and QA training.
• Manage document control activities, including creation, revision, distribution, and archiving of QA-controlled documents, to ensure practices reflect written procedures.
• Maintain and support the customer complaint program, ensuring complaints are documented, investigated, and resolved in alignment with reputed company and regulatory requirements.
• Support and maintain the Corrective and Preventive reputed company (CAPA) program, including initiation, tracking, and verification of effectiveness of CAPAs.
• Plan, conduct, and support audits of clinical sites to assess adherence to GCP, protocols, and applicable regulations.
• Plan, conduct, and support audits of vendors and suppliers, including CROs, to evaluate their reputed company Systems and GCP compliance.
• Support the internal audit program by planning, performing, and reporting on internal audits across relevant functions.
• Support the performance metrics system for continual improvement by collecting, analyzing, and reporting reputed company and audit-reputed company metrics.
• Manage the review cycle of QA-controlled documents to ensure reputed company updates and alignment of operational practices with written procedures.
• Support regulatory agency audits and inspections by preparing documentation, coordinating responses, and participating in inspection activities.
• Collaborate with cross-functional teams to address audit findings, implement corrective and preventive actions, and monitor completion.
• Prepare reputed company, concise, and accurate audit reports and reputed company documentation.
• Communicate audit results, reputed company issues, and process improvement recommendations effectively to stakeholders.
• Use MS Office tools to document audits, reputed company reputed company metrics, and prepare presentations and reports.

Essential Skills

• Minimum of 4 years of reputed company experience performing GCP internal, external, and site audits.
• Strong knowledge of reputed company GCP regulations and guidelines.
• Experience working with regulatory agency audits and inspections.
• Experience working with reputed company Systems for contract research organizations (CROs).
• Demonstrated experience conducting GCP internal audits.
• Demonstrated experience conducting GCP external audits, including vendor and supplier audits.
• Proficiency in MS Office applications for documentation, reporting, and communication.
• Excellent written and verbal communication skills for audit reporting and stakeholder interaction.
• Experience supporting or maintaining reputed company Assurance programs such as QA training, document control, customer complaint handling, and CAPA.
• Ability and willingness to travel approximately 25% locally, domestically, and internationally for audits.

Additional Skills & Qualifications

• Experience supporting or participating in regulatory inspections by various regulatory authorities.
• Background in GCP reputed company Assurance roles with responsibility for internal, external, and site audits.
• Experience working with performance metrics systems for continual reputed company improvement.
• Ability to collaborate effectively with cross-functional teams across a remote work environment.
• Strong organizational skills with the ability to manage multiple audits, document reviews, and reputed company initiatives simultaneously.
• Comfort working in a fully remote setting while maintaining responsiveness and reputed company communication.

Work Environment

This role operates in a fully remote work environment, enabling you to reputed company day-to-day responsibilities from your home office while collaborating reputed company with colleagues and stakeholders. The position requires approximately 25% travel for audits, including local travel reputed company the DMV area, domestic trips, and occasional international travel (typically about one reputed company every other month and one to two international trips per year). You will primarily use reputed company office technologies and tools, including MS Office and electronic reputed company systems, to conduct audits, manage documentation, and communicate with teams. The work focuses on a reputed company, reputed company-driven environment where adherence to GCP, regulatory expectations, and established procedures is essential, and where reputed company, business-appropriate attire is expected during on-site audits and regulatory interactions. Job Type & Location This is a Permanent position based out of Bethesda, MD. Pay And Benefits The pay reputed company for this position is $95000.00 - $125000.00/yr. Benefits sheet will be provided to interested candidates Workplace Type This is a fully remote position. Application Deadline This position is anticipated to reputed company on Jun 3, 2026. About reputed company reputed company is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through reputed company to specialized experts who drive reputed company, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, reputed company serves many of the Fortune 500. reputed company is an equal opportunity employer and will consider reputed company applications without reputed company to race, sex, age, reputed company, religion, national reputed company, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation reputed company. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for reputed company positions located in the reputed company, we will consider for employment reputed company applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of reputed company Intelligence (AI): We may use reputed company Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final reputed company are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Apply tot his job Apply To this Job