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Contract QA Associate, Document Control

Employer
Worldwide Clinical Trials - USA
Location
Austin, Texas, United States
Salary
Competitive
Start date
25 Jun 2022
Closing date
23 Jul 2022

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What the QA Associate, Document Control does at Worldwide

The QA Associate, Document Control is responsible for supporting the development and maintenance of GxP Quality Management Documents (QMDs) in compliance with Worldwide’s Quality Management System (QMS). The individual performs document control activities, develops tools and ensures consistency and compliance with applicable standards for procedural document development by functional collaborators and Process Owners in alignment with Worldwide’s procedures for QMD lifecycle management.

What you will do
  • Perform document control activities for Worldwide’s Quality Management Documents (QMDs), including SOPs, work instructions, forms, and templates in an GxP environment.
  • Maintain Worldwide’s Document Management SharePoint access portal, including controlled document data revision, tracking, revision schedules and metrics reporting.
  • Manage external distribution of QMDs to support project teams, audits and inspections.
  • Collaborate with internal stakeholders to support compliance with Quality Management System (QMS) and QMD lifecycle requirements.
  • Format, QCs and publish QMDs and other deliverables under tight timelines with exceptional accuracy.

What you will bring to the role
  • High level of proficiency with Microsoft applications, including Word, Excel, SharePoint and PowerPoint.
  • High level of proficiency in the English language, including written, oral and reading skills. Copy editing experience helpful.
  • Strong critical thinking skills and exceptional attention to detail
  • Strong teamwork and interpersonal skills, including internal customer service focus.

Your experience
  • Bachelor’s degree with concentration in the life sciences or other relevant work experience.
  • Prior experience with document management systems strongly preferred.
  • Experience managing GxP procedural documents preferred.
  • Understanding of the drug development process preferred.

Why Worldwide


At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!

#LI-MH!

#IND-MH1

Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

Brief Company Description; 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 2,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Company info
Mini-site
Worldwide Clinical Trials - USA
Location
600 Park Offices Drive
Suite 200
Research Triangle Park
NC 27709
United States

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