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Scientist (IVD)  (Closed)

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Position

Scientist (IVD, Rapid Diagnostic)

About Our Client

Founded in 2002, Company specializes in the development and manufacture of high quality rapid immuno-diagnostic products to serve the point-of-care market place including medical professionals, physicians, clinical laboratories and hospitals.

Job Summary

Scientist position is responsible for device production at Production Department and /or development of new device at R&D Department, in various stages. He/she has basic knowledge of biology, immunology or biochemistry, handles various laboratory equipment, and calculates basic biochemical terms.

Job Description

• Duties
• ? Independently manufacture Devices in various stage to meet product specifications. Follow schedules and plan production batches to assure on-time delivery of finished product.
• ? Utilize commonly used immunoassay laboratory techniques and instruments
• ? Perform tests to assure that products meet existing requirements for accuracy and precision.
• ? Evaluate raw materials to assure they meet requirements for quality.
• ? Performs technical troubleshooting by conducting technical assessment of products whenever requested by manager.
• ? Maintenance of laboratory supplies and glassware. Monitor and maintain the proper operation of general lab environment and instrumentation. Ensuring that all laboratory equipment is properly maintained and calibrated.
• ? Maintain good written records of laboratory procedures, results and conclusions. Perform and report interim analysis of accumulated data to monitor work process. Concludes results from raw data to meaningful terms, e.g., numbers, graphs or simple forms.
• ? Maintain familiarity with Quality System requirements. Demonstrated understanding of quality requirements that relate to both business needs and regulatory standards.
• ? Demonstrates strong documentation practices and consistently produces high quality products and documentation. Keep all records. Keeps a detailed laboratory log, dating, and recording all tests and results.
• ? Write, review and revise as necessary, manufacturing, material specifications, QC protocols, and many other documents for clarity, appropriate technical content, process improvements, scale-up and/or raw material changes as prescribed by policies and procedures.
• ? Communicate project updates and issues to supervisor. Accurately record and make detailed observations, analyze data, interpret results and issue reports.
• ? Understands and complies with ethical, legal and regulatory requirements.
• ? This job has no supervisory responsibilities.
• Duties at R&D Department
• ? Designs and/or develops new products, including possible proprietary items, according to the organization’s Product Development plan. Researches, creates and builds prototypes to satisfy product design specifications.
• ? Assists in the planning, design, and development of test requirements and/or specifications; directs and performs testing of prototypes accordingly to verify product reliability and performance requirements.
• ? Report to R & D Manager.

Qualifications

• ? B.S. in biology or a related field
• ? Experience in in vitro diagnostic technology or a related field is preferred
• ? Knowledge of regulations for Quality system requirement including cGMP, GLP.
• ? Ability to work well independently and with others.
• ? Ability to operate and maintain laboratory instruments.
• ? Ability to plan the use of equipment, materials and personal timework hour, and to complete production-related documentation accurately
• ? Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• ? Ability to work with mathematical concepts. Ability to apply statistical concepts to practical situations.
• ? Good communication skill and team player

What's On Offer

• Benefits : Health Insurance (Dental, Vision include), 401K, Severance program
• Vacation: 15 days (10 days vacations, 5 days sick leave)
• Work day & Hour: Mon to Fri 08:00 ~ 17:00 (1 hour lunch time_12:00~13:00)

Apply online or feel free to contact us directly for more information about the opportunity. Due to the high volume of applicant, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.


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