Quality Audit Specialist

Careers Signant Health • Whitpain Township, PA

20d • Hybrid

About The Position

The Quality Audit Specialist manages client audits and performs internal and vendor audits as needed. The role requires strong organizational skills and the ability to work with personnel at all levels, clients, and potentially regulatory investigators. The specialist is a self-starter who can articulate, receive, disseminate, and analyze information and documentation, and is responsible for all aspects of the audit process.

This position is hybrid and based in Blue Bell, Pennsylvania. It is mostly remote, but the successful candidate must be local and able to support client audits at the office as needed. The role also involves helping define and improve related processes, preparing audit materials and evidence, conducting audits professionally, and ensuring findings are handled in accordance with established procedures.

Requirements

• Previous knowledge and experience in audit and inspection management, including management of audit programs.
• Real-world auditing experience as a Quality Auditor.
• At least 3 years of relevant audit experience.
• Comprehensive knowledge of clinical trial processes, relevant regulations such as FDA, MHRA, and EMA, and ICH Guidelines.
• Strong critical-thinking skills to analyze complex situations, identify non-compliant issues, and recommend corrective and preventive actions.
• Strong understanding of software development and healthcare technology systems.
• Solid computer literacy and ability to work independently in a technology-reliant environment.
• Knowledge of governmental regulations affecting clinical research and drug development.
• Flexibility, open-mindedness, and adaptability in a rapidly changing environment.
• Ability to develop strong working relationships with key stakeholders and manage competing priorities.
• Must be local to support client audits at the Blue Bell office as needed.

Nice To Haves

• Familiarity with eCOA, IRT, Patient Engagement, Scale Administration, and Rater Training.
• Knowledge of GxP Computerized Systems.
• Demonstrated technical knowledge of GCP areas subject to audit.
• Familiarity with 21 CFR Part 11 relating to electronic records and signatures.

Responsibilities

• Host client audits from start to finish, including pre-audit preparation and post-audit responsibilities.
• Assist with defining and improving processes related to the role.
• Prepare for audits by ensuring documentation, subject matter expertise, systems, and other evidence are available and well organized.
• Conduct and host audits professionally and courteously, employing current best practices.
• Ensure valid audit and inspection findings are managed effectively and in accordance with established procedures.
• Collaborate with management to review and address issues and findings.
• Perform internal and vendor audits as needed.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed