Job Summary
- To carry out routine microbiology laboratory operations, this includes full range of cleanroom environmental monitoring activities, and product related testing activities;
- Expected to be competent in own area of scope (i.e. Environmental Monitoring or Product Testing), include rendering support and guidance to other team members in the organisation on non-routine microbiological testing for validation and engineering studies, and resolution of causes to operational issues;
- To assist with reviewing of microbiological test data, laboratory investigations in the absence of the lab manager or person in charge;
- Ensure testing elements (e.g. methods, equipment, and lab practices) are in compliance various regulatory requirements;
- Act as approved signatory for ISO/IEC 17025.
Job Responsibilities
- Perform routine/non-routine microbiological testing on raw materials, in-process samples, finished products (pre and/or post sterilize), as well as environmental monitoring according to WI
- Perform quality checks for media used in testing
- Review product/environment microbial trends, highlight emerging trends, uncommon bacteria occurance
- Coordinate 3rd party lab microbiological testing activities (e.g. bacterial identification, endotoxins test)
- Qualify and maintain respective laboratory equipment to ensure they are fit for its intended usage, with proper calibration and maintenance program established
- Ensure continuous flow of all necessary resources (e.g. supplies, trained analysts, equipment) to enable smooth activities in the laboratory
- Ensure accuracy, integrity, traceability and reliability of test report generated, as well as sample information submitted
- Maintain and prepare work instructions to ensure compliance with reference standards
- Lead laboratory equipment and test method validation / revalidation activities through establishing protocols, execution, and report documentation
- Provide support for personnel qualification and re-qualification, and cleanroom re-qualification
- Perform and/or support investigation and documentation of non-compliance or out-of-spec situations.
- Lead and/or review internal laboratory investigations
- Responsible for respective training activities for newcomers and qualify them on microbiological test methods
- Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment
- Monitor documentation and implementation of ISO/IEC 17025.
Job Requirements
- Bachelor in Science discipline (e.g. Pharmaceuticals Science, Microbiology, Biological Science)
- At least 2-3 years of relevant experience in a laboratory environment
- Cleanroom/environmental control experience is essential
- Good knowledge of microbiological test methods (e.g. Bioburden, endotoxins, sterility tests)
- Knowledge of aseptic techniques, and GLP
- Excellent Interpersonal and communication skill
- High level of integrity, a self-starter and ability to work independently
- Able to work under stress and deliver work schedules
- Knowledgeable of applicable standards such as ISO 13485, ISO/IEC 17025, preferably to have knowledge on ISO14644, ISO17141, ISO11737 and ANSI/AAMI-ST72
- Experience in Quality Assurance or medical device/manufacturing environment would be an advantage
- Relevant Microsoft Office Applications
- Preferable to have experience in QMS audit/internal audit/supplier audit in the context of ISO13485/9001 or the equivalence
- Good analytical and problem solving skills (FMEAs, 5-whys, 8D etc…)
