We are hiring a Diploma or Bachelors in biology, biomedical, life sciences, or relevant fields. The ideal candidate has competency in molecular laboratory techniques such as qPCR. Also, the candidate should possess the willingness to learn and demonstrate adaptability in a dynamic, fast-paced environment. He/she must also possess excellent communication and documentation skills. Previous exposure to ISO13485 processes will be an advantage. The person will be responsible for maintaining inventory and executing production processes while keeping good documentation and adhering to ISO13485 standards.
Key responsibilities
Liaise with contract manufacturer as main Point of Contact on timely production processes for manufacturing of IVD assays and medical devices according to projected demand
Perform timely production processes for manufacturing of IVD assays and kit components according to projected demand
Manage raw materials, reagents, consumables and inventory stock for manufacturing related activities
Support implementation and quality assurance for manufacturing with contract manufacturers
Support QC activities (incoming raw materials QC, outgoing kits QC, etc)
Generate proper documentations pre- and post- laboratory activities, review documentation for production and QC processes
Maintain QMS and participate in audit for ISO13485
Skills required
Well acquainted with basic molecular biology techniques and qPCR
Highly organized and meticulous in delivering and documenting tasks
Collaborative with excellent communication skills
Preferred experience
Equipped with knowledge of molecular diagnostics and assay production
1-3 years start up or industry experience
Have experience with generation of production and QC documents such as Bill of Materials, Manufacturing Work Instructions, Quality Work Instructions, process validation, etc.
Minimum education qualification
Diploma or Bachelors in biology, biomedical, life sciences, or relevant fields
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