Senior Qc Specialist
2 weeks ago
As a Senior QC specialist supporting our clinical trials in Singapore and abroad, you will be part of a team responsible for ensuring patient safety through testing of our therapeutic product and its intermediates. You will also be expected to actively participate in assay development and validation, as well as in OOS, RCA, CAPA implementation, and may be called upon to perform additional duties in support of the company’s cGMP activities.
**Responsibilities**:
- To conduct in-process QC tests, final product release tests and stability study
- To perform method validation on flow cytometry and qPCR methods.
- To maintain and clean analytical instrument routinely
- To complete test records and generate COA
- To analyse and review test results, procedures and reports generated
- To create SOP, test reports and logbooks
- To track events and trend data accumulated from test performed
- To monitor critical parameters and seek improvement in test methods continuously.
- To lead the development and validation of analytical assays
- To support in environmental monitoring program and gowning qualification.
- To support in change control, deviation, OOS, CAPA
- To support in technology transfer for analytical assays
- To lead in root cause analysis and troubleshooting of analytical test failures
- To establish training program for analytical method and provide training to users
**Requirements**:
- professional experience with flow cytometry, qPCR, cell culture, immunology and assay development/validation
- A bachelor’s degree in biomedical science, microbiology, cell biology or equivalent
- Minimum 3 years’ relevant laboratory experience
- GMP experience is a plus
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