EXECUTIVE - QA (MICROBIOLOGIST)

DUTIES AND RESPOSIBILITIES

• Perform standard microbiological tests for conformance to company, standards, regulatory and specification. Uses a variety of standard laboratory equipment and instrumentation.
• Perform test for final sterility, endotoxin, bioburden, efficacy etc. on raw materials, in-process and final product using standardized and validated methods per company, compendia and regulatory requirements.
• Prepare materials necessary for performing and executing validations. Assures instruments are calibrated within specifications and function properly in accordance to SOPs.
• Assures microbiological media are properly qualified, prepared, tested for sterility and growth promotion, assuring confidence of usage in preparation of product testing and environmental monitoring.
• Maintains records of all testing and analysis information of assigned raw materials/ processes/ products on predetermined forms for permanent file and proper entry of information on laboratory forms assuring data integrity is maintained throughout all processes.
• ·Assist in writing and updating standard operating procedures as related to microbiology and as required following company validated procedures and regulatory mandates. Evaluate all data obtained from analysis, identifies discrepancy or deviation, consult with superior and recommends any additional testing.
• Reports laboratory and manufacturing problems to superior as related to testing by using available facilities, known techniques and professional expertise to define potential root causes.
• Perform investigative testing on projects and other laboratory duties related to microbiology test methodologies.
• Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgement in the analysis of facts or conditions regarding individual problems or transactions to determine what action to be taken within the guidelines or standard practice.
• Assist in drafting quality reports for special studies.
• Maintain a good housekeeping, good laboratory practice and aseptic technique in the laboratory environment.
• Participates in employing involvement team.
• Any other duties as assigned by superior.

REQUIREMENTS

• Bachelor Degree in Microbiology, Biotechnology, Biochemistry, Environmental Science or any related field.
• Minimum 2 years of working experience in the related work scope.
• Must have hands-on experience in lab.
• Experience working with antimicrobial substance or product is an advantage.
• Good knowledge in good laboratory practice and aseptic technique.