Audit Coordinator

3 days ago

Blue Bell, United States Signant Health Full time

Quality Audit Coordinator

This is a REMOTE role based in the US
This could be the Opportunity 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?
We're looking for a new Audit Coordinator for one of our Quality teams working on the collection and communication with Audit team and clients. The position gives you a great view on Regulatory expectations and great collaboration with various internal team members.

The team is working on continued cross collaboration within our organization. Prior knowledge of general Microsoft products, communication, typing and organization skills are seen as an asset.
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**:

- Support team activities including:

- 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.
- Supplier Compliance - Monitor and track supplier performance by gathering relevant data and supporting the Quality Audit Lead as needed.
- Internal Audits - Assist as needed.
- Partner with key cross-functional teams to ensure effective audit management.
- Prepares and assembles audit record documentation for audit host(s).
- Participates in audits to capture and transcribe meeting record documentation.
- Ensures audit record compliance.
- Prepares and sends all documentation to audit host and team for review.
- Performs other clerical duties and tasks to improve productivity and ways of working.
- Liaise with internal and external partners to develop strong diligence according to internal policies regarding audit management.
- Assess, document, and communicate audit exposure across enterprise.
- Make recommendations on internal tools and processes to gain efficiencies in audit management activities.
- Translate customer needs into internal directions/activities which lead to client solutions.
- Support needs before, during and after audits and inspections
- Maintain and organize audit folders.
- Work closely with peers on timely completion of client commitments
- Establish and update procedures where appropriate

**You’ll need to bring**:

- High school diploma, GED, or equivalent
- Must have experience with GCP
- Professionalism, confidentiality, and organization
- Administrative writing and typing skills
- High level of organizational skills and record-keeping
- Ability to pull reports or extract data when needed
- Ability to work effectively under critical deadlines
- Robust communication skills and attention to detail
- Excellent interpersonal, shown written and verbal communication & follow-up skills

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

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

And finally, here are the ways of working that will help you succeed at Signant:

- You enjoy problem-solving and have a constructive can-do attitude.
- You’re motivated by working in a fast-growing global company.
- You’re self-driven, active and want to continuously learn new things.
- You have great communication skills in English, both spoken and written, and can articulate technical details succinctly.
- You like to share knowledge as a way to advance organizational learning.

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 401K Plan
- Generous paid time off
- Minimum of 4 weeks paid parental leave
- Pet insurance discount
- Modern and collaborative global office spaces

Does this sound like something you’d like to explore? Then we’d love to hear from you
Please note that Signant does not accept unsolicited resumes from Third Party v

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