Qc Specialist

2 days ago

Singapore MiRXES Pte Ltd. Full time

**QC Specialist**

MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.

Job Location**: Tukang**

**Job Summary**

The QC Specialist will work as part of the Quality team to support the QC of day-to-day operations and maintain detailed records for all the tasks assigned. The individual will inspect the products in different stages of manufacturing process such as incoming raw materials, intermediates, in-process and finished good. The individual will also participate in the investigation of nonconforming products and follow-up with the actions that arises from these inspections.

**Roles and Responsibilities**
- Perform routine QC testing of incoming materials, in-process materials, and finished goods.
- Plan and schedule daily QC routine and ad hoc runs assigned by QC supervisor.
- Evaluate data and create reports, highlighting any notable deviations from current standard operating procedures.
- Raise nonconformance for failures resulting from QC runs.
- Support troubleshooting/investigation of nonconformance to determine root cause of the failure.
- Responsible in drafting/revising of QC work instructions.\
- Support validation and stability studies across lab development and Diagnostic products, if necessary.
- General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab reagents, etc.
- Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.
- All listed tasks and responsibilities are deemed to be essential to the functions, but business conditions may require reasonable accommodations for additional task and responsibilities.

**Desired Skills and Competencies**
- Degree/ Diploma in Biomedical Science, Biotechnology, Molecular Biology, Biochemistry, Life Science related courses or equivalent.
- Have qPCR knowledge and experience in using qPCR machine.
- Proficient with the use of standard equipment such as pipette, centrifuge, etc.
- Familiar with the basic laboratory procedures. Relevant experience with laboratory testing, and QC of assays-based workflow will be an advantage.
- Able to work independently with mínimal supervision and with others within and outside his/her function.
- Excellent organizational and time management skills.
- High degree of initiative and ownership.
- Possess a positive and willing-to-learn attitude.
- Good interpersonal and communication skills.
- Basic computer competency, including familiarity with Microsoft Office, is highly desirable.
- 2-3 years of relevant experience in quality control and preferably in medical device manufacturing industry.
- Good understanding of GDP and cGMP are preferred.

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