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Quality Assurance Associate, Document Control - Serbia - Remote

Employer
Worldwide Clinical Trials
Location
Nottingham, United Kingdom;Homeworking
Salary
Competitive
Start date
16 May 2022
Closing date
27 May 2022

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Discipline
Regulatory Affairs
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 a 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
  • Serves as a Champion of Worldwide’s Quality Management System (QMS); specifically, implementation of and compliance with the QMD policy for process management
  • Performs document control activities throughout the entire QMD Lifecycle, including but not limited to QMD development, deployment, revision, retirement, storage, maintenance, tracking and reporting for GxP procedural documents, in alignment with Worldwide’s QMS
  • Contributes to the preparation of and participates in the Quality Management Document Governance Committee (QMD-GC) meetings
  • Collaborates with internal stakeholders to ensure compliance with the QMS and applicable QMD lifecycle procedures
  • Assists with the maintenance of the QMD Master Index, QMD Deviations and other QMD management tools
  • Manages the process for external dissemination of Worldwide’s QMDs
  • Supports Worldwide’s Audit & Inspection Program with Document Control related activities.
  • Executes on individual goals for the QA organization
  • May participate in departmental or cross-functional initiatives, as assigned
  • The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive


What you will bring to the role
  • Communicates professionally, positively, effectively, concisely, clearly and consistently to external and internal customers, both verbally and in writing
  • Client focused approach to work
  • Demonstrates critical thinking skills
  • Demonstrates organizational and detail-oriented skills, with exceptional follow through
  • Maintains a positive, results oriented work environment, builds partnerships within QA and across the organization at large, modeling teamwork
  • Serves as a positive QA ambassador during all daily activities and customer interactions
  • Proven ability to manage and prioritize workload, while meeting all deliverables and timelines
  • Works with a sense of urgency and recognizes and delivers on time sensitive deliverables
  • Works with supervision and has a flexible approach to work assignments
  • Provides constructive feedback to employees


Your experience
  • Proficiency in English, including speech, reading, and writing is essential.
  • Experience in managing GxP procedural documents is preferred.
  • Experience in supporting Regulatory Inspections is an asset
  • Working knowledge of ICH Guidelines, FDA regulations, European Directives, and MHRA Statutory Instruments
  • Understanding of the Drug Development Process
  • Proficiency with Microsoft based applications, including in Excel, Word, SharePoint, and PowerPoint. Experience with Electronic Document Management Systems (e.g., TrackWise is an asset.)
  • Bachelor’s degree with concentration in the life sciences or other relevant work experience
  • Domestic and international travel required (less than 10%)


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!

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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 3,000 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.

 

Company info
Website
Mini-site
Worldwide Clinical Trials
Telephone
+44 115 956 7711
Location
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom

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