Quality Assurance Auditor I

Everest-Clinical-Research; Warszawa; Hybrid; PLN 140,000 - 190,000; Full time

Job summary

Everest Clinical Research in Warsaw, Poland, offers a Quality Assurance Auditor I position with hybrid work options. The role focuses on conducting internal audits, maintaining SOPs, and supporting external audits to ensure regulatory compliance.

You will train staff on QA procedures and investigate non-conformities while staying current with industry best practices and regulatory guidelines.

Qualifications

• 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 (FDA, Health Canada, EMA, etc).
• ICH and GCP knowledge.
• QA/QC processes and training concepts.

Responsibilities

• Complete scheduled internal audits to assess compliance with applicable 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 per SOPs and update tracking databases.
• Assist with external audits by clients and regulatory inspections.
• Assist in QA staff training on QA procedures.
• Assist with investigation of non-conformities.
• Keep abreast of best practices in QC and QA through training and associations.

Skills

Analytical skills

Creative problem solving

Verbal & written communication

Detail-oriented

Organizational & multi-tasking

Microsoft Office

Education

Bachelor's degree in health science/physics/biology/mathematics

QA/auditing concepts certificate (preferred)

Tools

Microsoft Office

Job description

Job Category: Quality Assurance and Compliance

Requisition Number: QUALI002755

• Posted : August 19, 2026
• Full-Time
• Hybrid

Locations

Showing 1 location

Warsaw, WA 02532, POL

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. Everests 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 or from our office in Warsaw, Poland.

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 companies' 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

Bachelors 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.

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.