Controlled Document Coordinator

Working as part of the Global BiopharmCMC Lab operations team based in Harrogate, North Yorkshire, the Controlled Document Controller is responsible for performing departmental document control activities as they relate to regulatory systems (e.g. SOP/Forms, AP/WDs, archiving etc.). As part of the DCS team, support proactive and reactive activities which may arise within the Quality Control laboratory areas, liaising with Equipment Management, Facilities and IT as appropriate to ensure operational downtime is kept to a minimum. The Controlled Document Controller is a 12-month fixed term contract role with potential to go full-time or lead to other opportunities within Labcorp. Key Duties

• Support in the management of the BioPharmCMC SOP and controlled forms systems
• Support in the archiving of study/non study related documentation
• Support in the GMP documentation system supporting QC Operation (APs/WDs)
• Manages the document process by coordinating documents for review, approval and publishing
• Works to streamline processes and harmonize with best practices
• Assists staff with appropriate documentation for SOP and method requests
• Assists with audits in response to questions regarding documentation practices
• Responsible for the regulatory compliance of all functions within their scope
• Ensures that any work performed within the Division is carried out to the required standards, and that all study work is conducted in compliance with applicable regulatory requirements, specifically those regulations (GMP / GLP / GCP) specified in the study plans, protocols or work agreements
• Perform other related duties as assigned
  
  Are you someone who takes pride in their work, has great attention to detail and is also used to working to tight deadlines?, GCSE level or equivalent including English and Maths, Ideally some experience of working within the scientific industry or has the desire to do so
• Excellent attention to detail and can work to strict deadlines
• Experience of document control is beneficial
• An up-to-date knowledge of regulatory guidelines is desirable
• Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project)
• General management and interpersonal skills to participate in a positive culture and collaboration within internal project teams
• Good communication skills to be able to communicate effectively at all levels internally as well as with external clients, suppliers, etc.
  
  Labcorp Drug Development has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Chances are, you or someone you know has benefitted from a medicine or medical device that Labcorp Drug Development helped develop. As one of the world's premier Contract Research Organisations, Labcorp Drug Development's mission is to help build a healthier and safer world by providing research services for a multitude of organizations.


• Competitive salaries.
• Excellent benefits including above market pension scheme and holiday allowance.
• No mandatory weekends or evenings
• Career development opportunities.
• Opportunity to make an impact with your work!