- Document and review executed procedures and record data in compliance to Quality System specifications.
- Support Return material authorization (RMA) activities.
- Documentation review and release of incoming raw materials and final products release in compliance to internal specifications.
- Perform general lab maintenance (i.e. ordering of lab consumables).
- Tests and inspects incoming materials using standard operating procedures.
- Perform routine and non-routine analytical, molecular and biochemical assays according to business needs.
- Maintenance / calibration / inspection of measuring devices, equipment and procedures for accuracy.
- Report abnormalities and support troubleshooting / investigation of laboratory equipment/test/nonconforming material.
- Participate in developing and validating testing methodology, revising and updating Standard Operating Procedures.
- Perform Peer review to the test/inspection report.
- Perform release at SAP system.
- Diploma in Biomedical Sciences, Life Sciences, Biotechnology, Chemistry or related discipline.
- At least 3-5 years of relevant experience of quality assurance/ quality control experience preferred.
- Good understanding of GDP and cGMP, knowledge of ISO and FDA requirements preferred.
- Understanding and working knowledge in Geometric Dimensioning & Tolerancing.
- Must have working knowledge of acceptance sampling plans and basic statistics.
- Proficient with the use of standard measurement tools such as calipers, micrometers, height gage, thread gages and pin gages etc. Experience in CMM and Vision Measuring Systems are desirable.
- Familiar with basic laboratory procedures. Relevant experience with laboratory testing and QC of molecular-biology-based assays will be an advantage.
- Must have computer skills and competent in Microsoft Office Applications.
- Good written and oral communication skills.
- Must be able to identify and recommend effective solutions to problems and working individually and with others within and outside his/her function.
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Quality Technician - Singapur, Singapore - Illumina
Description
What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Position Summary:
This individual will work as part of the Quality team to support the QA/QC operations. The individual will be responsible for incoming inspection of raw materials, reagent and components, performing qualification of in-process and final products in the reagent QC; and outgoing inspection of device history review (DHR) for final products release. Individual will also assist in documentation review and NC process that arises from these inspections.
This individual will also be required to commit to 12 hours shift work depending on the business requirements.
Responsibilities:
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Education:
Preferred Requirements:
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
