Basic Function and Scope of the Position:
This individual will work as part of the Quality team to support the QC operations. The individual will be responsible for incoming inspection of raw materials, reagent and components, performing qualification of in-process and QC of final products; and outgoing inspection of DHR for final products release. Individual will also assist in documentation review and NC process that arises from these inspections.
Tasks and Responsibilities:
- Perform general lab maintenance (i.e. ordering of lab consumables)
- Participate in developing and validating testing methodology, revising and updating Standard Operating Procedures.
- Perform routine and non-routine analytical, molecular and biochemical assays to support release, characterization and stability testing of raw materials (IQC), production intermediates and final goods.
- Maintenance / calibration / inspection of measuring devices, equipment and procedures for accuracy.
- Document and review executed procedures and record data in compliance to Quality System specifications.
- Report abnormalities and support troubleshooting / investigation of laboratory equipment/test/nonconforming material
- Support Return material authorization (RMA) activities.
- Perform batch record review of final product prior lot release.
- Monitors inspection measuring devices and procedures for accuracy.
- Verifies and log customer returns & nonconforming materials.
- Supports nonconforming material investigations.
- Works directly with internal customers / other functions to convey requirements and resolve first level issues and deviations.
- May contribute to the planning and prioritization of workload to achieve goals. May be responsible for maintenance of work instructions, SOPs and training of other associates.
- Other such duties that may be determined by Management
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.
- Diploma in Biomedical Sciences, Life Sciences, Biotechnology, Chemistry or related discipline.
- At least 5 year of relevant experience of quality assurance/ quality control experience.
- Good understanding of GDP and cGMP, knowledge of ISO and FDA requirements preferred,
- Familiar with basic laboratory procedures, QC of molecular-biology-based assays
- Good communication and writing skills.
- Proficient using computers including Microsoft office programs: Word, Excel, Powerpoint, etc.
- Relevant experience with incoming, in-process or outgoing inspection will be an advantage.
- Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
- Ability to read, interpret and understand technical and non-technical supplier control documents including product drawings, specifications, contracts and purchase orders.
- Ability to understand and follow work instructions and perform laboratory assays with little guidance.
- Ability to execute routine task assigned based on approved procedure and work instructions
- Ability to effectively communicate with all levels of operations.
- Self starter, organized, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
- Good knowledge of geometrical dimensioning & tolerance.
- Ability to understand and follow work instructions and perform inspections with little guidance.
- Able to commit to permanent day shift work (3 to 4 working days per week - 8am to 8pm).
Illumina Singapore Pte Ltd
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.4 billion in 2016. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its “World’s Smartest Companies” list each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven en