Quality Assurance Administrator

  • Location:

    Cambridge, Cambridgeshire

  • Sector:

    IT, Healthcare

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Job ref:

    098765781_1603114860

  • Published:

    about 1 month ago

  • Duration:

    6 Months

  • Client:

    Undisclosed Company

Quality Assurance Administrator

6-month Contract - Potential extension

Cambridge

My client a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics, is looking for a Quality Assurance Admin Assistant who will be responsible for contributing to the efforts of the QA team by supporting standard processes for document development, management, and control, complaints, non-conformance, change control processes, complaints work-flow and compliance record work-flow.

Responsibilities:

  • Providing support to Global, Business, and Site Quality Assurance personnel with regard to the development and control of quality system documentation
  • Supporting the development and maintenance of document standards, naming/numbering conventions, and templates for QMS procedures, work instructions, and other relevant document types
  • Supporting implementation of employee training around document management and control with training personnel as required
  • Ensuring the management and control of forms and reference documents that are directly related to the document management/document control elements of the Cytiva and site Quality Management System
  • Provide administrative support for document work-flow and ensuring compliance with relevant global & site procedures and work instructions
  • Support and provide daily management of the process for maintaining document cross references
  • Ensure the identification and removal of old/obsolete procedures and work instructions from across global & site and establishing oversight to avoid the duplication of QMS documentation
  • Developing presentations and compiling reports in preparation for Change Control Board, Complaints handling Unit and Quality Assurance meetings and reviews
  • Assisting in the authorship of site quality management system related procedures and work instructions as required
  • Leading quality assurance doc control efforts by actively leading or participating as a member of cross-functional improvement teams as required.
  • Support local projects as required

Quality Assurance Administrator Criteria:

  • Bachelor degree (or high school diploma/GED plus 1 years' experience in administration of document control or compliance record management
  • Minimum 1-year experience working in medical device, clinical, or pharmaceutical environment or similarly regulated industry
  • Some knowledge of medical device and/or pharmaceutical regulations (FDA, ISO preferred) 2. Coursework in Quality Assurance/Control and/or Regulatory Assurance (preferred)
  • Process improvement mindset, passion for quality
  • Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation)
  • Demonstrated effective interpersonal and effective teamwork skills
  • Excellent oral and written communication skills
  • Some experience of analytical & problem-solving skills/root-cause analysis
  • Strong organisational skills with high attention to detail 9. Prior experience using word processing, spreadsheet, and presentation software
  • Ability to effectively multi-task (i.e. effectively handle competing priorities)
  • Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
  • Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations
  • Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
  • Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remain calm in challenging or frustrating circumstances

If you feel you would be suitable, please send in your CV.

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