Quality Audit Specialist

(Remote role within commute distance to Blue Bell, PA)
Are you ready for the Most Impactful Work of Your Life?
Signant Health is a global evidence-generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations, and reimagining the path to proof.
Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry.
Where do you fit in?
The Quality Audit Specialist is responsible for managing client audits along with performing internal audits and vendor audits as needed. The candidate must have well-developed organizational skills and have the ability to interact with all levels of personnel, our clients, and potentially regulatory Investigators. Candidate must be a self-starter and a results-oriented individual with the ability to articulate, receive, disseminate and analyze information and documentation. The individual would be responsible for all aspects of the audit process.
Roles and Responsibilities
As part of our team, your main responsibilities will be:
1. Host client audits, from start to finish which would include all pre-audit work and post-audit responsibilities.
2. Assists with defining and improving all related processes within the remit of the role.
3. Prepare fully for upcoming audits to ensure all possible documentation, subject matter expertise, systems and other forms of evidence are fully available and in best order.
4. Conduct and host audits professionally and courteously and ensure best current practices are employed.
5. Ensure valid findings from the audit/inspection report are managed effectively by the organization, and in accordance with our procedures.
6. Collaborate with management to review and potentially correct issues and findings.
7. Perform internal and vendor audits as needed.
8. Attend in-person audits in our Blue Bell, PA, office once or twice per month.
You’ll need to bring:
1. Previous knowledge and experience in audit and inspection management, and management of audit programs.
1. Real-world auditing experience having worked as a Quality auditor.
2. Minimum 3 years of relevant audit experience
3. Comprehensive knowledge of the clinical trials process, relevant regulations (e.g., FDA, MHRA, EMA), ICH Guidelines.
4. Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions.
5. Strong understanding of software development and healthcare technology systems.
6. Solid computer literacy and able to function independently within an environment that relies on technology for information and communication.
7. Knowledge of governmental regulations impacting clinical research and drug development
8. Flexibility, open-mindedness and adaptability to a rapidly changing environment; able to develop strong working relationships with key stakeholders; able to manage competing priorities.
We’d be thrilled to hear that you also have:
1. Familiarity with eCOA, IRT, Patient Engagement, Scale Administration, Rater Training
2. Knowledge of GxP Computerized Systems
3. Demonstrated specific technical knowledge of the GCP areas subject to audit.
4. Familiarity of 21 CFR Part 11 relating to electronic records and signatures
And finally, here are the ways of working that will help you succeed at Signant:

• You have a constructive can-do attitude and can adapt quickly to change.
• You’re motivated by working in a fast-growing global company.
• You’re self-driven, active, and want to learn new things continuously.

We know that everyone has different wants and needs, which is why along with a highly competitive base salary, we support our people and their loved ones with a variety of perks and benefits.
As part of our team, some of the benefits you can expect to receive are:

• Our Long-Term Incentive Plan, which is unique to the industry.
• The flexibility to work remotely.
• Comprehensive health, dental, and vision insurance
• A competitive retirement plan.
• Generous paid time off

Does this sound like something you’d like to explore? Then we’d love to hear from you!
Please apply below.
We review and respond to every application, keep an eye on your inbox for our reply.
Please note that Signant does not accept unsolicited resumes from Third Party vendors.
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At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

Health insurance, Dental insurance, Paid time off, Vision insurance, Retirement plan