Amalina Hashim

• Sample management of routine and non-routine samples
• Perform Aliquoting on Process and Non-Protein samples on a daily basis
• Perform Depyrogenation to support Micro testings
• Perform peer review for verification of task and data related to Sample Management
• Manage controlled documents/forms and make sure SOPs are periodically reviewed and updated
• Ensures good inventory of critical materials via QC Kanban system to support testing
• Manage Laboratory Consumables, Services and Chemicals/Biologics in Takeda’s Requisition System (ARIBA)
• Manage of QC Reference Substances, Controls and Critical Reagents
• Assists in the review and writing of SOPs related to Sample and Inventory Management in QC labs
• Identify and report any excursion / atypical issues / safety concerns in QC to Supervisor in a timely manner
• Assists in closure of deviation in QC where applicable
• Responsible in closure of investigation of deviation in QC where applicable
• Provided guidance and training to new hires
• Adhere to Good Manufacturing Practices (GMP)

Other General Responsibilities:

• Carry out 5S and ensures good housekeeping of Lab Services area
• Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk)
• Disposal of samples based on related SOPs
• Projects - CAPs and Adherence of TAT results
• Adhere to laboratory safety procedures to maintain compliance with quality control standards
• Participated in lab meetings and project presentations

• Sample Management of routine and non-routine samples
• Performed aliquoting on Process and Non-Protein samples on a daily basis
• Performed peer review for verification of task and data related to Sample Management
• Ensured good inventory of critical materials via QC Kanban system to support testing
• Maintained records of Laboratory Consumables, Services and Chemicals/Biologics raised purchased requisition in COUPA
• Assisted in the review and writing of SOPs related to Sample and Inventory Management
• Identified and reported excursion / atypical issues / safety concerns in QC to Supervisor in timely manner
• Prepared buffers/in-house reagents for Total Protein and Potency Testing
• Supported in the closure of deviations in QC
• Supported Microbiology lab with Autoclave and Depyrogenation
• Adhered to Good Manufacturing Practices (GMP)

Other General Responsibilities:

• Carry out 5S and ensures good housekeeping of Lab Services area.
• Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk)
• Adhere to any applicable EHS requirements

• Developed a small scale formula of product (mainly pesticides/insecticides) and perform QC test before bulk production
• Performed Quality Control (QC) testing on final product and incoming raw materials
• Investigated and resolved issues related to laboratory processes and procedures
• Prepared reagents and solutions following standard laboratory formulas and procedures
• Maintained and calibrated equipment used on a daily basis such as, not limited to, Balances, pH meter, Gas Chromatography (GC) and High-performance Liquid Chromatography (HPLC) Adhere to Safety and Regulations of workplace
• Troubleshoot and conducted cause analysis of non-conforming products
• Method development and validation in GC and HPLC
• Recorded and interpreted laboratory results to present to senior colleagues
• Conducted real-time stability studies to access product quality
• Gathered laboratory samples, monitored fluids and read test results to make accurate care decisions
• Provided technical guidance and training to laboratory staffs
• Developed and implemented standard operating procedures (SOP) to verify quality control
• Developed new protocols and improved existing laboratory processes
• Prioritized work assigned, maintained accurate records of work performed and initiated corrective action in case of defective records or inadequate care plans
• Participated in lab meetings and project presentations

• Worked both independently and collaboratively in fast-paced clean-room laboratory environment
• Maintained up-to-date records of research activities and results for future reference
• Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations
• Collaborated with other researchers to develop successful research strategies and formulated a new coating for new contact-lenses products
• Conducted stability studies on the shelf-life of existing contact lenses
• Assisted scientists by collecting and organizing laboratory data
• Assisted R&D team with on-going projects and assignment
• Prepared reagents and solutions following standard laboratory formulas and procedures
• Cooperated with other technicians to develop and test new protocols