Quality Audit Coordinator - Legal; Risk & Compliance

This could be the Opportunity of Your Life!

Working at Signant Health puts you at the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry. We’re radically changing the clinical trial landscape, driving change through the technology and innovations we create and the services we deliver to our customers.

Where do you fit in?

This team focuses on providing support to the Audit Management team. 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.  Candidate is primarily responsible for assisting and supporting the management of client audits, however may support Supplier and Internal audits as well.

Want to join the Best Team of Your Life?

We’re looking for people who are excited by the potential to make a difference in the world. You don’t need to have a clinical background to thrive at Signant. You need to be decisive, open to celebrating mistakes, able to communicate transparently and inclusively, and someone your team can count on. Most of all you need to be yourself! 

As part of our team, your main responsibilities will be: 

1. Support team activities including:
   1. Client Audits – supports with document retrieval, coordinating and drafting responses to observations, populating trackers/systems, preparing the conference room or virtual room for audits, etc.
   2. Supplier Compliance – Monitor and track supplier performance by gathering relevant data and supporting the Quality Audit Lead as needed.
   3. Internal Audits – Assist as needed.
2. Partner with key cross-functional teams to ensure effective audit management.
3. Prepares and assembles audit record documentation for audit host(s).
4. Participates in audits to capture and transcribe meeting record documentation.
5. Ensures audit record compliance.
6. Prepares and sends all documentation to audit host and team for review.
7. Performs other clerical duties and tasks to improve productivity and ways of working.
8. Liaise with internal and external partners to develop strong diligence according to internal policies regarding audit management.
9. Assess, document, and communicate audit exposure across enterprise.
10. Make recommendations on internal tools and processes to gain efficiencies in audit management activities.
11. Translate customer needs into internal directions/activities which lead to client solutions.
12. Support needs before, during and after audits and inspections.
13. Maintain and organize audit folders.
14. Work closely with peers on timely completion of client commitments.
15. Establish and update procedures where appropriate
16. Other responsibilities as assigned.

Decision and Making Influence

1. Train and mentor other team members.
2. Maintain documents and records in accordance best practices and applicable regulations etc.

You’ll need to bring: 

1. High school diploma, GED, or equivalent.
2. Professionalism, confidentiality, and organization.
3. Administrative writing and typing skills.
4. High level of organizational skills and record-keeping.
5. Ability to pull reports or extract data when needed.
6. Ability to work effectively under critical deadlines.
7. Robust communication skills and attention to detail.
8. Excellent interpersonal, shown written and verbal communication & follow-up skills.
9. Ability to easily learn various software applications.
10. Lives in the greater Philadelphia area to support on-site external audits.

We’d be thrilled to hear that you also have:

1. 1-3 years of experience working in a pharmaceutical industry is preferred.
2. Knowledge of clinical trial terminology and process.
3. Knowledge of GxP quality standards, applicable regulations, and software development risks.
4. Minimum of 60 WPM preferred.

Does this sound like something you’d like to explore? Then we’d love to hear from you!

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