**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials **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. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.