SHL MEDICAL

Microbiologist

Full time         Taoyuan, Taiwan          Posted: Aug, 2017

Description

SHL is seeking an experienced Microbiologist to provide support to the QA Department and the company in the areas of microbial environmental monitoring, sterilization, problem solving, validations, new product support, and internal/external regulatory compliance.

Your Responsibilities

  • Perform or coordinate a wide variety of microbiological tests in accordance with approved protocols; summarize the results in a final report or qualification
  • Responsible for implementation of new tests and new technologies, as well as the improvement of existing tests
  • Assist in maintaining compliance to Quality system and external regulatory bodies by keeping up-to-date with and implementing current regulations and industry standards
  • Apply thorough knowledge in the concept of internal and external regulatory requirements (QSR, ISO, EN) in the following subjects: microbial environmental monitoring, contamination control, and quality assurance
  • Participate in the internal audits of department test methods and activities to confirm compliance and to identify improvement opportunities
  • Responsible for writing cleanroom validations and supervising the testing and data summary of activities related to the cleanroom validations
  • Strong knowledge of all microbiology routine test methods and schedules, including bioburden, LAL, environmental monitoring, sterility and Particulate Testing
  • Responsible for facilitating partners and internal shareholders for test method validations. Ability to lead problem- solving investigations in the event of test method failure for product failures
  • Review equipment qualifications on major pieces of equipment, such as autoclaves, refrigerators, and incubators
  • Support Regulatory submissions by conducting the 1st phase review to ensure appropriate microbiology information is present in the submission. Some of the participation may include writing the initial draft of the microbiology summary and compilation of reports
  • Review test reports from internal, external testing for compliance and external compliance requirements. Review trend analysis data, generate trend reports and review monthly metrics
  • Support other facilities (including product transfer) by forwarding copies of applicable reports/data and coordinating tests as needed
  • Provide lab support by conducting routine tests, solution preparation, and data collection as needed
  • Support new product introductions (PDP) by participating as the microbiology (QA- Microbiology) functional team member
  • Author non-conformance reports and CAPA reports; co-ordinate with other departments for timely closure of reports
  • Assist with regulatory audits at the site and help assist supplier audits (may be required to travel)
  • Other duties assigned as needed

Your Qualifications

  • Bachelors/Masters in Science/Microbiology with 4 to 5 years’ experience in medical device industry, preferably in Microbiology
  • Experience in performing environmental monitoring of Cleanrooms, writing CAPA’s and investigation reports
  • Strong quality assurance background; familiar with ISO11137 & ISO29701: 2010 within a Good Manufacturing Practice (GMP) and FDA regulated environment
  • Proficiency in microbiological techniques such as Aseptic Testing, Microbial Monitoring, Gram staining, plating, or membrane filtration
  • Knowledge of statistical analysis techniques is a plus
  • Knowledge of statistical analysis techniques is a plus
  • Ability to manage multiple projects with limited supervision
  • Excellent written and verbal communication skills

What We Offer

  • Competitive compensation package
  • Modern working environment with state-of-the-art facilities and technologies
  • Challenging tasks in a fast growing and innovative industry
  • Position in a young, dynamic and international team of highly skilled professionals
  • Opportunity to work independently and contribute personal ideas to the success of SHL

For further information on this position or SHL Group, please contact contact our Human Resources Department: Margo.Hao@shl-group.com