Quality Assurance Audit Specialist

Who We Are:

TransPerfect’s Trial Interactive is an industry leader in practical, global eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world.

What You Will Be Doing:

The Audit Specialist at Trial Interactive is responsible for overseeing the planning, coordination, and execution of both internal and external audits. This role involves responding to audit findings, ensuring compliance to quality standards, and leading efforts to enhance inspection readiness. The Audit Specialist plays a pivotal role in developing and enhancing audit management processes and systems to ensure continuous regulatory compliance.

The Audit Specialist is responsible for performing the following activities, but also all other tasks that are deemed appropriate by their supervisor:

Planning and Hosting Client Audits:

• Lead the preparation and planning of client audits.
• Coordinate schedules, gather necessary documentation, and ensure efficient audit processes.
• Manage client inquiries and facilitate communication between clients and internal teams during audits.
• Respond to audit reports by leading internal reviews and driving the resolution of client audit findings.

Internal and External Audits:

• Conduct and lead internal QA audits, identifying areas for improvement and ensuring compliance with quality standards.
• Support vendor/supplier audits by coordinating data collection and report generation.
• Conduct regulatory gap assessments, identifying and addressing potential compliance issues.

Inspection Readiness:

• Collaborate with cross-functional teams to improve inspection readiness by maintaining accurate documentation and implementing QA best practices.
• Lead ongoing projects aimed at improving audit processes and overall compliance readiness.

Who We Are Looking For:

Required Skills:

• Proficient in quality assurance (QA) processes and audit management.
• Excellent organizational skills with attention to detail.
• Strong communication and interpersonal skills for working with clients, team members, and stakeholders.
• Ability to lead and mentor Audit Associates.
• Strong familiarity with IT concepts and software tools (e.g., spreadsheets, audit management software).
• Ability to work both independently and as part of a team.

Required Experience and Qualifications:

• Minimum Bachelor’s degree in a related field (or equivalent experience).
• 3-8 years of experience in quality assurance, audit coordination, or related fields such as regulatory compliance or IT systems support.
• Proven track record in conducting audits and managing audit-related tasks.
• Experience in regulated industries (e.g., pharmaceutical, healthcare).

Desired Skills and Experience:

• Any previous experience in QA, audit preparation, or data management
• Familiarity with IT and/or Computer System Validation (CSV) concepts
• Experience in regulated industries (e.g., pharmaceutical, healthcare)

Where Your Career Is Going:

At TransPerfect, there are a lot of growth opportunities. All departments offer career growth and development that can combine your skills, interest and experience. We encourage our employees to have a continuous dialogue with management about growth opportunities throughout your tenure with the company.

End your job search and find your career at TransPerfect #careersNOTjobs.

Why TransPerfect:

For more than 25 years, we have honed a culture where all kinds of ideas are shared and new ventures are not only welcomed, but also encouraged. In this fast-paced environment, employees are intellectually stimulated so they can grow alongside the organization. From Intern to President, we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.

We also offer a comprehensive benefits package including medical, dental, and vision insurance, 401k matching, membership to child-care providers, and other TransPerks. You even get your birthday off because let's face it, we're stoked that you were born.

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

TransPerfect is committed to all recruitment processes and workplace free from harassment, sexual harassment & discrimination.

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.