QA ASSOCIATE, DOCUMENT CONTROL
Company: Worldwide Clinical Trials
Posted on: May 16, 2022
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
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
Strong critical thinking skills and exceptional attention to
Strong teamwork and interpersonal skills, including internal
customer service focus.
Bachelor's degree with concentration in the life sciences or other
relevant work experience.
Prior experience with document management systems strongly
Experience managing GxP procedural documents preferred.
Understanding of the drug development process preferred.
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!
Keywords: Worldwide Clinical Trials, Houston , QA ASSOCIATE, DOCUMENT CONTROL, Other , Houston, Texas
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