QC Microbiologist

QC Microbiologist

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Make Quality Lead - Malaysia

Locatie:

Asia Pacific, Malaysia, Selangor, Petaling Jaya

Werklocatie:

Volledig ter plaatse

Wat je gaat doen

To provide overall quality support for Quality System activities, implemented from product development through to commercialization and distribution, in the manner that complies with Regulatory, GMP, Safety Health and Environment and corporate quality standard. Ensure all projects are executed, validated and well documented to ensure compliance with cGMP & Kenvue policy.

1. Leadership & Kenvue-Way Behaviors

• Demonstrate integrity and model Kenvue-Way actions in all activities.

• Apply strategic thinking with strong attention to detail and big-picture awareness.

• Collaborate effectively across teams with a sense of urgency and accountability.

• Exhibit intellectual curiosity, adaptability, self-awareness, and a results-driven mindset.

2. Quality Systems & Compliance Management

• Develop, implement, maintain, and continuously improve Quality Management Systems (QMS) supporting product development, manufacturing, and release.

• Maintain continuous audit and inspection readiness of the manufacturing site.

• Administer and support QMS platforms, including NC, CAPA, documentation and records systems, and the Learning Management System (LMS).

• Ensure GMP documentation, specifications, and manufacturing work instructions are accurate, current, and controlled.

• Ensure compliance with SOPs, Good Documentation Practices (GDP), and Data Integrity requirements.

• Track documentation and record status to ensure timely revision, closure, and reconciliation.

• Support and lead global and local quality initiatives, improvement projects, and Kenvue Production System activities.

• Support the site’s Indirect Supplier Management program, including supplier qualification, approved supplier list management, quality agreements, and performance monitoring.

3. Microbiology Operations & Testing

• Prepare and qualify microbiological media, including pH, sterility, fertility, and growth promotion testing.

• Maintain stock cultures and perform microorganism identification.

• Conduct plant hygiene and environmental monitoring, including water, air, compressed air, and post-CNS monitoring, with defined sampling plans and trending.

• Perform end-to-end microbial limit testing for raw materials, bulk, and finished products, including incubation, result reporting, and batch micro release.

• Perform and support microbiology-related OOS investigations for facilities, materials, products, and components.

• Support hygiene- and MRA-related change management initiatives involving personnel, facilities, equipment, and validation.

4. Equipment Qualification & Maintenance

• Perform laboratory equipment qualification and annual equipment reviews.

• Manage equipment calibration and preventive maintenance programs according to schedule.

• Investigate equipment-related issues, including calibration out-of-limit (OOL) and environmental monitoring failures.

5. Laboratory Purchasing & Inventory Management

• Manage procurement of laboratory chemicals and consumables.

• Coordinate laboratory inventory levels and stock availability.

• Liaise with external suppliers regarding purchasing, availability, and payment.

• Support laboratory budget tracking and cost management.

6. Continuous Learning & Team Development

• Stay current with new technologies and best practices through collaboration with Kenvue affiliates and originating companies.

• Build strong technical knowledge of products and materials to support new product introductions and improvement projects.

• Provide coaching, mentoring, and technical guidance to new team members.

7. GLP, GMP & EHS Compliance

• Ensure adherence to GLP, GMP, and EHS policies and laboratory regulations.

• Maintain clean, safe, and orderly laboratory workstations in line with company requirements.

What We Are Looking For

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific discipline.

• Experience in microbiology and quality systems within a GMP manufacturing environment.

• Strong knowledge of GMP, GLP, GDP, Data Integrity, and Quality Management Systems.

• Hands-on experience in environmental monitoring, microbiological testing, and OOS investigations.

• Experience with electronic QMS and documentation control systems.

• Strong analytical skills, attention to detail, and ability to manage multiple priorities.

• Effective communicator with the ability to collaborate across functions.

Preferred Qualifications

• Experience in a multinational or regulated FMCG/pharmaceutical manufacturing environment.

• Exposure to regulatory inspections, audits, and continuous improvement initiatives.

• Experience supporting training systems, supplier quality, and equipment qualification.

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