Quality Documentation & Training Administration

Location
Cambridgeshire
Salary
On Application
Posted
27 Nov 2018
Closes
27 Dec 2018
Ref
CWi
Discipline
Quality, QA / QC
Contract Type
Contract

Key activities include the collection, quality control, approval routing, reporting, and management of critical documentation and data, and serving as a subject matter expert for the use of tools and systems that support these activities.

Quality Documentation and Training Administration - Cambridgeshire

Job Responsibilities 

  • Routine interactions and collaborations will typically include internal hiring managers, new hires, procedural document/training content owners, learning & development professionals from diverse cross functional and worldwide locations 
  • Supports operational aspects of the QMS as follows, 
  • Processes and triages content from the central department mailbox. 
  • Responds to customer inquiries/requests with support from a more senior professional.
  • Follows formal Quality Control procedures, assuring consistent high quality output is maintained. 
  • Maintains departmental spreadsheet(s) with up to date reference information. 
  • Archives and maintains quality records and correspondence. 
  • Contribute to generation of workload and quality metrics/reports and assists with distribution. 
  • Provides quality oversight through review and analysis of records/data for compliance and consistency with procedural and regulatory standards. 
  • May under supervision of a more senior professional assist with system/process improvement initiatives. 
  • May provide operational support during audits and regulatory agency inspections. 
  • May assist with delivery of system/process training. 

Training Administration: 

  • Administrates user privileges in validated Learning Management System (LMS). 
  • Enters content and associated metadata into (LMS). 
  • Assigns training credit to learners. 
  • Creates and assigns applicable training curricula to users. 

Document Control: 

  • Enters content and associated metadata into the electronic Document Management System (eDMS) 
  • Performs data integrity focused quality checks on documentation 
  • Enters documents into approval workflows following dedicated procedures 

Key Differentiating Contributions: 

  • Work is performed under supervision using well defined procedures and detailed instruction 
  • Contributes to aspects of interdepartmental projects 

Key Skills 

  • Strong attention to detail and ability to consistently meet high standards of quality required in a GxP environment. 
  • Systematic in obtaining and using information. 
  • Systematic in assuring the accuracy/quality of their own work. 
  • Capable of performing regular routine work tasks to a consistent high standard of reproducibility. 
  • Good understanding of formal business structure and organizational awareness. 
  • Good verbal, written, interpersonal communication and organizational skills. 
  • Good knowledge of Microsoft office programs eg Word and Excel. 

Requirements

  • BS or BA degree with no experience or 2+ years of relevant experience in absence of formal qualification. 
  • Experience working in a regulated or GxP environment is desirable. 
  • Familiarity with/use of validated document management and learning management system software, and applications eg Documentum, Veeva Vault, UL Compliance Wire is desirable. 

 

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