Quality Assurance Auditor II

Join Clario and elevate quality and compliance across our clinical services. In this role, you’ll lead advanced quality audits and assessments of Clario’s procedures, systems, and data to ensure regulatory compliance and the highest standards of service delivery.

What We Offer

• Competitive compensation and incentives

• Private medical coverage and MetLife protection

• SZÉP Card and telework reimbursement

• Flexible time off

• Engaging employee events and hybrid technology support

What You’ll Be Doing

• Plans, conducts, and reports audits according to Bioclinica’s standard operating procedures (SOPs) and electronic document management system (EDMS) processes

• Tracks and/or trends audit issues and/or CAPAs until closure

• Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned

• Champions timely management of quality event reports, audit findings, and CAPAs

• Follows-up and verifies effectiveness checks

• Reports metrics to her/his manager and Bioclinica management as required

• Ability to work with all levels of Bioclinica personnel and external personnel in a professional and organized manner

• Identifies and implements process improvements, with a focus on the audit program

• Supports all audit/inspection types (e.g. internal, external, vendor, regulatory inspections, registrar etc.})

• Support the tracking and trending of all compliance reports and audit activities

• Communicating effectively, verbally and in writing, with all internal and external clients

• Escalating quality concerns and problems to the Manager, Quality and Regulatory Compliance or designee(s)

• Performing QA review of source documents, case report forms (CRFs), and other reports for accuracy

• Working directly with Bioclinica development teams to ensure the accuracy and consistency of system development and validation deliverables.

• Supporting external (vendor/supplier) quality audits and hosts Sponsor audits

• Facilitate quality training of peers on quality related matters

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by:

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)

• Assisting in establishing and enforcing departmental and regulatory standards

• Developing or revising SOPs

Contributes to team effort by:

• Working with internal staff to resolve issues

• Exploring new opportunities to add value to organization and departmental processes

• Helping others to achieve results

• Performing other duties as assigned

Maintains Technical and Industry Knowledge by:

• Attending and participating in applicable industry or company-sponsored training(s)

What We Look For

• Bachelor’s degree or equivalent required, preferably in life sciences, trial or quality management, or computer science

• Quality and/or computer systems certification (e.g. ASQ Auditor), or equivalent, is preferred

• Approximately: 3+ years relevant experience in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries-preferably in Pharmaceutical, CRO, Biotech, Medical device

• Possesses a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, Software Validation requirements and is competent with quality management systems (QMS)

• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations

• Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)

• Understanding of medical and/or clinical trial terminology is desirable

• Ability to work independently and/or across cross-functional teams; ability to adjust to changing priorities

• Excellent attention to detail and orientation toward meticulous work

• Strong interpersonal and communication skills, both verbal and written

• Strong documentation and organizational skills

• Ability to manage multiple tasks effectively & efficiently

• Proficient at problem-solving

• Goal oriented

• Ability to project and maintain a professional and positive attitude

• Possess high-level ethics and integrity

At Clario, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.