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A leading medical device company in Penang is seeking a candidate with a degree in Microbiology or related fields. The role focuses on ensuring patient safety and product quality in laboratory environments. Responsibilities include executing tests, maintaining documentation, and supporting regulatory audits. Previous experience with laboratory equipment is advantageous. Candidates should demonstrate time management skills and a commitment to quality policies. This position offers a unique opportunity to contribute to innovative health solutions.
Uphold patient safety and product quality while ensuring compliance with cGMP, ISO 17025, and all applicable quality systems.
Execute laboratory testing according to established procedures and review all generated data and reports for accuracy and conformance to specifications.
Maintain complete, accurate, and controlled documentation, including notebooks, logbooks, datasheets, and electronic records.
Support investigations, Non-Conformance Events (NCEs), and Out of Specification (OOS) results, collaborating with operations and quality teams to resolve issues.
Coordinate and perform method validations, implementation of new tests and technologies, and continuous improvement initiatives.
Conduct equipment qualifications and requalification, preparing associated protocols and reports.
Participate in internal, external, regulatory, and vendor audits, providing necessary support and documentation.
Ensure laboratory personnel are trained and compliant with mandatory training programs.
Provide guidance and supervision to Technician I, II, and III roles, and serve as designee for senior microbiology staff when required.
Promote laboratory safety, environmental awareness, and health compliance.
Collaborate with cross‑functional teams and support other laboratory functions as needed.
Assist in developing, updating, and controlling laboratory procedures and work instructions.
Perform additional responsibilities as assigned by Laboratory Management.
Consistently demonstrate commitment to Quality Policy, patient safety, and product quality.
Ensure full compliance with all documented quality systems and procedures.
Degree in Microbiology / Food Technology / Biotechnology / Life Sciences or related disciplines.
Experience in setting‑up and maintaining laboratory equipment and instrumentation for routine tests and analysis will be an added advantage.
Passionate about laboratory analysis work with good time management.
Microbiological and Analytical Laboratory Skills will be an added advantage.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.