Ruth Tiongson Email & Phone Number

Bergisch Gladbach, North Rhine-Westphalia, De

Bergisch Gladbach, North Rhine-Westphalia, De

Bergisch Gladbach, North Rhine-Westphalia, De

Bergisch Gladbach, North Rhine-Westphalia, De

Boston, Ma, Us

Leverkusen, North Rhine-Westphalia, De

• Perform routine and non-routine microbiological testing of commercial and developmental products, in-process materials and raw materials by following standard operating procedures using a variety of methods. Collect, evaluate and record data, including computer data entry• Follow all good manufacturing practices and good laboratory practices, safety rules and department guidelines. Uses care and judgment in the use and handling of laboratory materials and equipment to maintain a safe, clean and orderly working environment;• Perform other duties as assigned (i.e. inventory management, cleaning & sanitization of biological safety cabinets).

Marlborough, Ma, Us

•Performs or coordinates a wide variety of microbiological or biological tests which are performed in accordance with approved protocols and summarizes the results in a final report or qualification. Review reports completed by other Microbiologists or Laboratory Technician.•Responsible for implementation of new tests, new technology, and improves existing tests.•Assists in maintaining compliance to BSC Quality system and external regulatory bodies by keeping up-to-date on current regulations and industry standards and by ensuring testing and test method are compliant to the external and BSC standards.•Thorough knowledge in the concept, internal (BSC) and external regulatory requirements (QSR, ISO, EN) in the following subjects: microbial environmental monitoring, biocompatibility, contamination control, and quality assurance.•Participate in the internal audits on department test methods and activities to confirm compliance and to identify improvement opportunity.•Strong knowledge of all microbiology routine test methods and schedules. Responsible for training new Microbiologists and Technician and for test method validations. Will be able to lead problem- solving investigations in the event of test method failure for product failure.•Support Regulatory submissions by conducting the 1st phase review to ensure appropriate microbiology and biocompatibility information is present in the submission. Some of the participation may include writing the initial draft of the microbiology summary and compilation of microbiology reports.•Review test reports from internal, external testing for compliance to BSC and external compliance requirements. Review trend analysis data and review of monthly metric reporting to Quality. •Support other BSC facilities (including product transfer) by forwarding copies of applicable reports/data and coordinating tests as needed.•Support new product introductions (PDP) by participating as the QA- Microbiology.

Abbott Park, Illinois, Us