Quality Administrator

  • £20.00 - 22.50 per hour
  • Location: Cambridge
  • Job Type: Temporary
  • Date posted: 21/10/19
Amanda Rushmer

Hi I'm Amanda,
I manage this role

Operations Director

Please get in touch if you would like to discuss this role


Job description

Job reference: 57/3

Owing to company growth, an exciting opportunity has arisen for an experience professional to join our Biotech client, based South of the City with free parking available.

Under the direction of a senior Compliance professional, you will be working as part of the Quality and Compliance team, supporting the company’s global compliance program through the provision of high-quality administrative support and maintenance of the quality management system.

Successful candidates must be degree educated and able to demonstrate 4+years’ experience in a relevant field, such as a Quality Control, Quality Assurance, Regulatory Operations or similar Regulated environments.

KEY ACTIVITIES

Primary Responsibilities

  • Administrates the electronic Document Management System (eDMS) and Learning Management System (LMS) including managing user accounts, assigning access rights and initiating workflows
  • Administrates Procedural Documents and Quality records through the eDMS,
  • Performs quality control of entered data and follows appropriate procedures to ensure the quality of information is compliant with global quality standards
  • Serves as functional liaison with local training coordinators at International affiliate locations
  • Addresses and resolves customer questions promptly, maintains close cooperation and communication with international affiliate personnel
  • Provides ongoing user support on system(s) and department processes
  • Supports the creation and implementation of globally standardised processes applicable to the quality management system and their deployment to affiliate locations
  • Provides support in regulatory agency inspections. May coordinate audit follow-up and corrective action planning with appropriate functional areas
  • Tracks and monitors department workloads ensuring business priorities are addressed
  • Maintains process metrics


CANDIDATE PROFILE

Knowledge, Experience and Skills

  • Must have experience managing content in an eDMS or LMS 
  • Must have excellent oral and written communication skills, as well as effective interpersonal skills, is able to work efficiently with customers and colleagues across geographical locations
  • Must be customer oriented but understand the compliance-driven nature of the role
  • Must be proficient with Microsoft Word and Excel (advanced skills preferred)
  • Must possess exceptional organisational and time management skills with ability to work on specified projects to tight timelines
  • Must be systematic in obtaining and using information
  • Must be able to develop and use systems to organise and check information, ensuring a high level of accuracy, quality and consistency
  • Must have exceptional attention to detail and ability to consistently meet high quality standards
  • Must have demonstrated ability and willingness to conduct routine work, such as data entry to a high standard of accuracy, while displaying flexibility and independence in spotting or anticipating/resolving problems
  • Experience corresponding with people who use English as a second language is an advantage

Specific Education and Experience

  • 4+ years of relevant experience with a BS or BA degree (or 3+ years with a Master’s degree) in a relevant field, such as a Quality Control, Quality Assurance, Regulatory Operations or similar GxP/Regulated environments.
  • Experience with eDMS eg Veeva Vault, MasterControl, Documentum is highly desirable


ADDITIONAL INFORMATION

Vacancy: Temporary (12 months via agency)

Rate: up to £22.50p/h doe

Hours: 37.5hrs per week

Start Date: Nov ‘19

Ref: 57/3

Next steps

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Quality Administrator (Ref: 57/3)

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