Do you want to be in a role that co-ordinates scientific analytical work?
Are you someone who takes pride in their work, has great attention to detail and is also used to working to tight deadlines?
Do you want the opportunity to work for a global scientific organisation that strives to make a difference to people’s everyday lives by bringing essential products to the market?
Labcorp Drug Development has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
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.
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.).
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
1. Support in the management of the BioPharmCMC SOP and controlled forms systems
2. Support in the archiving of study/non-study related documentation
3. Support in the GMP documentation system supporting QC Operation (APs/WDs)
4. Manage the document process by coordinating documents for review, approval and publishing
5. Work to streamline processes and harmonize with best practices
6. Assist staff with appropriate documentation for SOP and method requests
7. Assist with audits in response to questions regarding documentation practices
8. Responsible for the regulatory compliance of all functions within their scope
9. Ensure 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
10. Perform other related duties as assigned
Education requirements:
* GCSE level or equivalent including English and Maths
What Labcorp Drug Development can offer you:
* 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!
Experience:
* Ideally some experience of working within the scientific industry or has the desire to do so
* Excellent attention to detail and ability to 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.
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