Sterility Analyst Lead

ROLE AND RESPONSIBILITIES

  • The main aim of the role is to carry out sterility testing and to master the range of techniques appropriate for the work area. Become familiar with work practices and documentation requirements.
  • Preparing and conducting validation and performance qualification of new products.
  • Preparing and executing annual re-qualification protocols and sterility test validation protocols. Responsible for SOP generation and overseeing of all routine sterility testing in the Isolator
  • Responsible for all deviation investigation, root cause analysis and Laboratory investigations for the Microbiology department
  • Reporting client test results and acting to ensure all clients requirements are met.
  • Gain an insight into the processes / procedures of the company’s business including customer awareness, lab safety and efficiency.
  • Training additional analysts to support this area
  • Act on own initiative and to learn as quickly as possible any tests that they are required to do.
  • Responsible for gaining proficiency in a certain number of tests/area of testing.
  • Perform techniques / tests that they are qualified to do in terms of completed training records and as directed by the laboratory senior.
  • Ensure that all documentation and calculations are carried out on time, accurately and legibly
    Keep training records up to date and to initiate training as per training plan where possible when free from work
  • Adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
  • Ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
  • Identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.

EDUCATION/QUALIFICATIONS

  • A Degree or Diploma in Microbiology or a related discipline is desirable
  • 2+ years GMP experience
  • Background in Sterility

THE CANDIDATE

  • Good team player, organised, accurate, have strong documentation skills
  • Passionate about quality and customer service.
  • Good communication skills both internally and externally.
  • A good role model for junior

Contact: Anne O’Donnell E. aodonnell@cls.ie