Microbiologist II

Key Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025).
• Conduct testing according to written procedures.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Ensure all training is completed as per Laboratory Training Program 92048659.
• Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner.
• Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.
• Assist manufacturing/operations/quality personnel in solving quality-related problems.
• Ensures NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.
• Support Internal/External Audits.
• Provide direction to Technician I & II roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross functional project teams as required.
• Designee for Senior Microbiologist as required, by overseeing the day to day operation of the Microbiology laboratory.
• Co-ordinate and/or perform method validations of new products.
• Assists in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalification as assigned and write related protocols/reports.
• Documentation control – coordinates and updates documentation within the laboratory to ensure all documents are controlled in line with requirements.
• Coordinate and train to ensure compliance to mandatory training requirements.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Sn Microbiologist.
• Assist in writing and updating Procedures, Work Instruction.
• Perform and assist with additional duties as may be directed by the Senior Microbiologist.

Requirements

• Bachelor of Science in Microbiology, Biotechnology, Chemical, Industrial Science or any related field.
• Minimum 3 years of relevant working experience.
• Knowledge of microbiology principles, laboratory operations, and quality systems.
• Experience in a regulated manufacturing environment will be an added advantage.
• Ability to work independently and collaboratively in a cross-functional environment.

Required Skills

• Microbiological Laboratory Skills.
• Analytical Skills.
• Knowledge in Microbiology Medical Device Testing.
• Problem Solving Skills and Analytical Thinking.
• Data review and interpretation.
• Technical investigation and troubleshooting.
• Good communication and cross-functional collaboration skills.
• Understanding of cGMP, regulatory requirements, environmental control, and laboratory quality systems.
• Experience in test method validation and laboratory investigations will be an added advantage.