Work Schedule

Environmental Conditions

Job Description

Position Summary

Oversee daily maintenance and management of laboratory facilities, equipment, and materials to ensure safe, compliant, and stable operation. Independently conduct release testing for raw materials, in-process samples, and finished products (per quality standards). Assist in product/process equipment/facility Validation & Verification (V&V); support quality engineers and production lines in addressing quality defects/customer feedback; and participate in Corrective & Preventive Actions (CAPA). Enforce to company EHS (Environmental, Health, Safety) rules.

Crucial Job Functions and Accountabilities

1. Laboratory Operation & Maintenance

Manage daily cleaning, maintenance, upkeep, and status labeling of lab facilities/instruments.

Operate and maintain inspection equipment (including daily checks of measuring tools and calibration coordination).

Control lab reagents/consumables (procurement, receipt, storage, registration, distribution, expiration monitoring).

Ensure lab environment (temperature, humidity, cleanliness) meets requirements; conduct monitoring and documentation.

Maintain lab safety (wear PPE, keep work area organized per 5S); assist EHS in hazard identification, assessment, and risk control.

2. Inspection Execution

Follow company quality/environmental policies, SOPs, inspection methods, and WIs.

Monitor key production control points to meet quality and environmental standards.

Independently perform IQC (raw materials), IPQC (in-process), and finished product release testing; ensure accurate, timely results.

3. Record & Document Management

Comply with Good Documentation Practices (GDP) to fill out inspection records, equipment logs, and environmental data in real time, accurately, and completely.

Store and archive inspection records and raw data accurately.

4. Quality Support & Issue Handling

Assist in V&V for products, process equipment, and facilities.

Support quality engineers in investigating defects, deviations, and customer feedback; help develop and implement CAPA.

Report abnormalities/non-conformities/major quality issues promptly to production, technology, and quality teams.

5. Teamwork & Task Delivery

Communicate and collaborate with production, warehouse, and facilities teams for smooth workflow.

Complete superior-assigned tasks timely and efficiently; participate in safety, quality, and skill training.

Educational Qualifications

College diploma or above.

Preferred: Background in Biotechnology, Medical Laboratory Science, Molecular Biology, Immunology, Pharmacy, Analytical Chemistry, or related life sciences.

Experience and Other Qualifications

Preferred: Laboratory work experience (especially in medical devices or IVD reagents).

Familiarity with ISO9001/ISO13485; GMP/cGMP experience a plus.

Basic English reading/writing (understand English SOPs, handle work emails).

Proficiency in Microsoft Office (Word, Excel).

Strong communication, responsibility, teamwork, attention to detail, hands-on ability, and problem-solving skills.