Laboratory & Technical Services (Science & Technology)
Full time
The purpose of the Microbiologist III role is to conduct data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations workstreams. They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.
Key Responsibilities:
Demonstrate a primary commitment to patient safety and product quality.
Responsible for maintaining a full understanding and complying with all the regulations governing the quality system (including ISO 17025).
Ensure all training is completed as per Laboratory Training Program.
Co-ordinate and train to ensure compliance with mandatory training requirements.
Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
Provide technical guidance/troubleshooting in the event of Microbiology related issues.
Assist in the implementation of new tests, new technology, and improvements to existing tests.
Perform new equipment qualifications and re-qualifications as assigned and write related protocols/reports.
Provide direction to Technician roles and various operations workstreams.
Attend and represent the Microbiology Laboratory at various meetings and on cross-functional project teams as required.
Support Internal/External Audits and ensure all non-conformances are adhered to in a timely manner.
Designee for Laboratory Manager as required, by overseeing the day to day operation of the Microbiology laboratory.
Communicate any concerns about work process regarding environmental impact, health or safety issues to their Manager.
Perform and assist with additional duties as may be directed by the Microbiology Supervisor/Manager.
Additional key responsibilities include: Compile, Review and Report Environmental metrics; Calculate and review product bioburden alert limits and cleanroom air and surface alert and action limits; Establish and monitor appropriate Lab Metrics including Management Review support; Review and assess from a microbiology context all changes that impact product or the cleanroom environment including introduction of new products; Provide technical support on microbiology related issues to various operational departments.
Job Requirements:
Degree in Microbiology / Food Technology / Biotechnology / Life Sciences or related disciplines.
At least 5 years' relevant hands-on microbiological testing experience is a must.
Experience in setting-up and maintaining laboratory equipment and instrumentation for routine tests and analysis.
Possess knowledge or competent in Quality Management System, will be an added advantage.
Passionate about laboratory analysis work with good time management.
Microbiological and Analytical Laboratory Skills.
Knowledge in Medical Devices Microbiology testing, Cleanroom Qualification, and environmental monitoring of Cleanroom.
Expertise in Microbiology and Sterilization of Medical Devices.#J-18808-Ljbffr