OBJECTIVE AND MAIN TASK OF THE FUNCTION To contribute to the quality and safety of medical device products by performing microbiological testing and supporting quality control processes, while actively collaborating with cross-functional teams to ensure compliance with regulatory standards and drive continuous improvement in laboratory practices.
TASKS 1. Responsible for various laboratory testing for materials and product including
· Endotoxin Testing (LAL)
· Biological Indicators Evaluation
2. Collect water samples for testing (TOC, HPC, Conductivity) to be send to external supplier.
3. Compiles and documents data from test procedures to ensure accurate records and compliance with quality and regulatory standards.
4. Responsible for managing laboratory consumables, including inventory monitoring, organization, and timely ordering to ensure uninterrupted lab operations.
5. Assists in project planning, coordination, and tracking by supporting timeline development, maintaining project documentation, and facilitating communication between team members.
6. Supports the preparation of investigations, summaries, and reports by reviewing data for compliance with specifications and reporting any deviations or abnormalities.
7. Provide technical support to the QC Manager in troubleshooting, method development, and process improvements.
8. Responsible for maintaining and updating Standard Operating Procedures (SOPs) and Work Instructions (Wis) relevant to their functional area, ensuring documentation is accurate, current, and aligned with regulatory and operational requirements.
9. Support internal and external audits by preparing documentation, responding to auditor queries, and implementing corrective actions as required.
10. Foster strong collaboration with cross-functional teams (e.g., Quality Assurance, Manufacturing, Purchasing) to support shared goals and continuous improvement.
11. Carries out additional responsibilities as required to support the Quality Control function and adapt to evolving business needs.
REQUIREMENTS AND SKILLS Education: Degree in Microbiology, Biology, or related scientific field
Special Knowledge: Experience in a GMP-regulated laboratory environment, preferably within the medical device or pharmaceutical industry.
Strong knowledge of microbiological testing methods
and quality systems.
Familiarity with audit preparation, support, and follow-up
actions in regulated environments.
Ability to work independently as well as collaboratively in
In cross-functional teams.
Strong English skills, both written and spoken.
Comfortable in using MS Office (Excel, Word, Outlook)
for data entry, reporting, and communication.
Personality: Excellent organizational and communication skills, with
strong attention to detail.
Highly adaptable and flexible, able to work effectively
under pressure in a dynamic environment.
Demonstrates a strong sense of responsibility, integrity,
and commitment to team success.
Proactive learner with a logical, solution-oriented
mindset and a continuous improvement attitude.
Professional Experience: Experience in an FDA- and ISO 13485-regulated
Environment (medical device, pharmaceutical, or food
industry is required.
Minimum of 3 years of relevant experience preferred.
A combination of education and experience may be
considered.
Experience specifically within the medical device and/or
pharmaceutical industry is strongly preferred.
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