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Your Role:
As Associate Scientist – Technical Data Analysis (AS –TDA) you will designs and delivers Viral Clearance validation studies for biopharmaceutical companies across the APAC region. The AS - TDA is responsible for the preparation of Final Reports and Certificates of Analysis using data obtained from GLP/GMP assays performed across all Bioreliance Biotesting Lab in Singapore. In collaboration with the laboratory personnel, the AS - TDA summarizes the life cycle, technical processes and assay results of a sample in a Final Report. The AS - TDA will work closely with the Study Directors to prepare the study file and generate the final report on time. The AS - TDA will review batch records, process data and perform trend analysis data to ensure consistent assay performance and scientific integrity of the study.
The post holder need to have an understanding of technical/ scientific observations and ensure all documentation generated fulfills quality and regulatory standards and practices (GLP or GMP) as well as client specific requirements when reporting assays.
Summarizes technical data into a high quality report or certificate of analysis as required, in a timely mannerWorks closely with study management to prepare study files and perform technical data review of executed lab recordsIs familiar with study-specific protocols, technical specifications, applicable SOPs and regulatory requirementsPrepares study reports and any applicable study associated Final Report/Certificate of Analysis amendments according to specific client requests to achieve on time delivery. Addresses comments on these study reports following Study Director review and Quality Assurance auditGenerates, controls and tracks revisions to all appropriate Report/Certificate templatesLeads investigations and implements CAPAs and change controls ensuring records are closed in accordance with the assigned timelinesOwns projects to enable continuous improvement and drive a quality cultureEnsures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplaceReview Right First Time (RFT) metrics with the appropriate personnel in order to drive down error rates.Input dates into Information management systems and prepare study files for archivingReviews laboratory records and performs statistical analysis to calculate virus titers log reduction factorsProvides hands-on support to the lab team by performing virus titration assays, virus infectivity reads and virus titre calculations when requiredPerforms trend analysis to ensure the assay remains in the qualified state of controlPrepares system reports in support of huddles and metrics tracking
Who You Are
Master's degree in Biological Sciences or higher degree in relevant scientific subjectMinimum 2 years of experience in a scientific laboratory rolePrevious experience in scientific writingPrevious experience working in a regulated environment (GLP/GMP) would be advantageousComputer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)Ability to complete documentation (both handwritten and electronic) neatly and accuratelyAdheres to health and safety procedures and actively takes necessary action when encountering unsafe situationsAdheres to SOPs and protocols, and ensures compliance to site policies and regulationsPursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacksCustomer oriented and able to relate with clients from different culturesAble to maintain effective working relationships with scientists and other lab personnel will be critical for success in the role
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com