Quality Assurance Auditor I

Everest New Logo; United States; Remote; USD 14,000 - 20,000; Full time

Job summary

Everest Clinical Research, a leading CRO, seeks a Quality Assurance Auditor I for a remote position based in Romania. The role focuses on internal audits, regulatory compliance, and maintaining quality SOPs across processes.

Ideal candidates have a health science-related degree, 1+ year auditing experience, and strong knowledge of ICH/GCP guidelines. The company emphasizes quality, client service, and ongoing professional development.

Qualifications

• Bachelor’s degree in health science, physics, biology, or mathematics.
• Certificate in QA auditing concepts (preferred).
• At least 3 years’ of experience in a clinical research capacity.
• At least 1 year of auditing experience.
• Knowledge of clinical trial processes and procedures.
• Knowledge of pharmaceutical industry regulatory requirements (FDA, Health Canada, EMA).
• I CH and GCP guidelines knowledge.
• Excellent analytical and creative problem-solving skills.
• Detail-oriented with strong organizational skills.

Responsibilities

• Complete scheduled internal audits to assess compliance with regulatory requirements and Everest SOPs.
• Document and report audit findings in a timely manner.
• Follow-up on all compliance issues until resolution.
• Maintain governing documents according to SOPs and update tracking databases.
• Assist with external audits by clients and regulatory inspections.
• Assist in traineeQA procedures.
• Investigate non-conformities and drive corrective actions.
• Stay updated on best QA practices through training and industry activities.

Skills

Analytical thinking

Problem solving

Communication skills

Detail-oriented

Multitasking

Education

Bachelor’s degree in health science, physics, biology, or mathematics

Certificate in QA auditing concepts

Tools

Microsoft Office

Job description

Job Category: Quality Assurance and Compliance

Requisition Number: QUALI002757

• Full-Time
• Remote

Locations

Showing 1 location

Remote
Bucharest, ROU

Description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario Canada and US headquarters in New Jersey USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Quality Assurance Auditor I, working remotely in Romania.

Job Accountabilities

Complete scheduled internal audits to assess compliance with applicable regulatory requirements and
Everest Standard Operating Procedures (SOPs).

Document and report audit findings in a timely manner.

Follow-up on all compliance issues until resolution.

Maintain the company’s governing documents according to the SOPs including, but not limited to,
entering the governing document tracking information into a database, updating database records
when governing documents are updated, and reporting and following-up on outstanding SOP review
obligations.

Assist with external audits by clients and regulatory inspections.

Assist in the employee training of QA procedures.

Assist with the investigation of non-conformities.

Follow-up on industry best working practices in quality control (QC) and QA by researching and
participating in relevant training and/or association activities.

Requirements

Bachelor’s degree in health science, physics, biology, or mathematics.

Certificate in QA and auditing concepts (preferred).

At least 3 years’ of experience in a clinical research capacity.

At least 1 year of auditing experience.

Knowledge of clinical trial processes and procedures.

Knowledge of pharmaceutical industry regulatory requirements for differing governing bodies such as
FDA, Health Canada, European Medicines Agency, etc.

A comprehensive knowledge of ICH and GCP guidelines.

Knowledge of QC and QA processes and procedures, procedural document management, auditing,
and training concepts.

Excellent analytical and creative problem-solving skills.

Commitment to quality and process improvement.

Ability to provide timely quality deliverables.

Effective communication skills, orally and in writing, with personnel at all professional and
administrative levels.

Detail-oriented with exceptional ability to notice inconsistencies.

Well organized with strong multi-tasking skills.

Ability to concentrate on the assigned tasks over extended periods of time.

Comprehensive skills in Microsoft Office applications.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com .

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.