Lab Supervisor, Microbiology

Teleflex Medical Sdn Bhd

Kamunting

On-site

MYR 78,000 - 123,000

Full time

4 days ago
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Job summary

Teleflex Medical Sdn Bhd in Kamunting, Perak, Malaysia, seeks a skilled Microbiology Lab Supervisor to lead the microbiology team, oversee validation activities, and ensure quality, safety, and regulatory compliance. The role requires expertise in bioburden and endotoxin testing, technical reporting, and cross-functional collaboration.

The position focuses on maintaining laboratory operations, developing testing strategies, and ensuring timely, accurate results for medical device manufacturing

Qualifications

  • Supervisory experience in a microbiology lab.
  • Experience with bioburden and endotoxin testing.
  • Knowledge of QMS and GDP requirements.
  • Ability to write technical reports.

Responsibilities

  • Supervise a team of lab analysts and set work direction.
  • Plan workload, priorities, and resources to meet testing deadlines.
  • Develop and support validation strategies for microbiology tests.
  • Maintain and calibrate microbiology equipment.
  • Lead method validation, transfer, and implementation.
  • Monitor and ensure bioburden/endotoxin testing compliance.
  • Communicate test status and timelines to stakeholders.
  • Review test results per QMS and GDP.
  • Lead nonconformance investigations and corrective actions.
  • Prepare technical and investigation reports.
  • Manage inventory and lab supplies.
  • Coordinate procurement and external services.
  • Maintain risk controls for staffing/equipment.
  • Develop training programs for analysts.
  • Support sterilization revalidations and product changes.
  • Serve as Microbiology SME on cross-functional projects.
  • Ensure safety and biosafety compliance.

Skills

Supervisory
Lab planning
Validation strategies
Equipment maintenance
Method development
Bioburden testing
Endotoxin testing
QA documentation
Root cause analysis
Technical reporting
Inventory management
Procurement coordination
Risk management
Analyst training
Sterilization revalidations
Cross-functional SME
Safety compliance

Tools

Laboratory equipment
Calibration
QMS

Job description

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Operations -

Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totolly Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Hirer responsiveness Salary match Number of applicants

Teleflex is a company that believes in values of Entrepreneurial Spirit, Building Trust and Make It Fun centered around People – our greatest asset.

We are the medical product division of Teleflex Incorporated, a large American MNC, manufacturing and distributing high quality health care products. Our factory is located in Kamunting, Perak and we manufacture sterile disposable medical devices for the urology, anaesthesia and respiratory markets. Our values are focused on customers, growth, leadership and people.

Teleflex is a company that believes in values of Entrepreneurial Spirit, Building Trust and Make It Fun centered around People – our greatest asset.

We are the medical product division of Teleflex Incorporated, a large American MNC, manufacturing and distributing high quality health care products. Our factory is located in Kamunting, Perak and we manufacture sterile disposable medical devices for the urology, anaesthesia and respiratory markets. Our values are focused on customers, growth, leadership and people.

  • Supervisory responsibilities and set work direction for a team of lab analysts.
  • Plan and manage laboratory workload, testing priorities, capacity, staffing, and resources to ensure timely execution of routine testing and project-related activities while maintaining quality and compliance requirements.
  • Develop and support validation strategies for microbiological test methods, including bioburden and bacterial endotoxin testing, as required to support laboratory and business needs.
  • Ensure microbiology laboratory equipment and facilities are maintained in a qualified, calibrated, safe, and fit-for-purpose condition, and coordinate required maintenance, calibration, qualification, and corrective actions.
  • Lead and support the development, validation, verification, transfer, and implementation of microbiological test methods, including evaluation of method suitability and robustness, to support laboratory capability and business needs.
  • Monitor execution of routine product bioburden and/or bacterial endotoxin testing. Ensure testing is performed in accordance with approved procedures, applicable standards, and established laboratory requirements.
  • Establish clear communication of test status, issues, and expected timelines to stakeholders.
  • Review and approve test results generated by the microbiology lab according to QMS and good documentation practices
  • Lead and support laboratory nonconformance, deviation, OOS/OOT, and investigation activities, including root cause analysis, impact assessment, corrective actions, and effectiveness monitoring.
  • Prepare, review, and approve microbiology technical reports, investigation reports, impact assessments, and other laboratory documentation to ensure technical accuracy, completeness, and compliance with applicable QMS and GDP requirements.
  • Manage laboratory inventory and supplies to ensure adequate availability for routine and project activities, while identifying and implementing opportunities for process, efficiency, capacity, and cost improvements.
  • Identify and coordinate laboratory procurement and external service requirements, including equipment, consumables, calibration, maintenance, and laboratory services, in alignment with business needs and approved budgets.
  • Maintain laboratory capability and business continuity by identifying and mitigating risks related to staffing, equipment, materials, facilities, testing capacity, and operational disruptions.
  • Develop, coordinate, and maintain analyst training and competency programs for microbiological test methods, laboratory procedures, good documentation practices, and applicable quality requirements.
  • Execute testing to support sterilization cycle revalidations and product change assessments
  • Serve as the Microbiology Subject Matter Expert (SME) for cross-functional projects, product and process changes, validation activities, investigations, audits, and regulatory inspections, providing technical microbiology guidance and recommendations.
  • Ensure microbiology laboratory activities are conducted in accordance with applicable laboratory safety, biosafety, and chemical safety requirements, and promote a safe working environment for laboratory personnel.

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