Controlled Document Coordinator

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.

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.

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

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 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 is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply

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