· Follow and perform all assigned duties in according to the standard operating procedure (SOP) in an FDA regulated (ISO 13485) lab environment and operate with good manufacturing practices (cGMP).
· Adhere to applicable regulations, policies and procedures for Environmental health and safety compliance (EH&S).
· Handle, store, and dispose of hazardous bio-chemicals materials and waste following safety training protocol.
· Participate in manufacturing, optimizing, evaluation, modification, and improving clinical chemistry latex immunoassays (Cardiac Troponin I, Adiponectin, Lipoprotein (a), H-FABP, D-Dimer, hsCRP, Kappa Lambda Free Light Chain) and enzymatic assay (Fibrinogen).
· Optimize and evaluate assays using data statistical analysis based on previous lots' data to maintain lot to lot traceability, run real-time and accelerated stability testing on chemistry clinical analyzers (Roche Hitachi 917, Modular P, AU400, AU680, cobas c501 and architect c8000).
· Write, edit, and submit Master Batch Records, memos, quality plans, validation reports for product manufacture and improvement.
· Examine and qualify critical raw materials (antibody, latex particles) by testing small scale and submitting validation reports before use for large scale usage and production.
· Work in a cross-functional team to communicate with management, supervisor, QC/QA and R&D to plan, maintain, troubleshoot and improve product functionality/quality.
· Contact vendors to order unvalidated samples, raw materials, and lab equipment.
· Train new employees and create written instructions for the various tasks.
· Adjust production processes to optimize manufacturing processes, increase productivity and reduce waste.
· Proven ability to work as a person in charge and manage the store when possible.
· Ability to train and assist new employees, ordering goods when needed.
· Improved communication and leadership skills.
· Developed customer service and problem solving skills.
· Proficient in recording data and evaluating the quality of food.
· Supported the store to reach the target sales.
· Trained new team members in cash register operation, stock procedures and customer service.
· Created and optimized employee schedules to secure proper coverage for all shifts.
· Created food displays according to established standards, replacing dated products with fresh.
· Promoted specific item options to drive sales and achieve add-on purchases.
· Assisted manager/manager assistant with completing end-of-day counts and securing funds to prevent loss or theft.
· Counted cash drawer at end of shift and prepared bank deposits.
· Complied with safety and sanitation guidelines to maintain health and well-being of customers and other staff.
· Delivered key administrative support to coworkers, taking on additional tasks during peak times.
· Maintained high standards of customer service during high-volume work shifts and fast-paced operations.
· Restocked napkins, condiments and utensils at self-service areas during slow periods.
· Assisted and conducted experiments and maintained detailed records of experiments and outcomes.
· Conducted and supported research, including collection of information and samples.
· Data analysis, Laboratory and Lab notebook maintenance; Familiar with gel image analysis and data labels.
· Experienced practicing many laboratory techniques (Elisa, Western Blotting, cDNA, PCR, qPCR).
· Efficiently Performing Polymerase Chain Reaction technique: Digestion, Purification, PCR set up, Gel making, Loading. Using PCR and RT-PCR machine.
· DNA Recombinant technique: PCR amplification, Quantification, Cloning, Ligating, Transformation.
· Basic experienced handling mice.
· Prepared buffer and maintained cell culture; Sterile technique for tissue culture and cloning.
· Utilized various instruments and equipments: pipetting device, microscopes, centrifugal equipments, tissue culture safety cabinets, incubators for tissue culture, incubators/shaker for bacterial culture, vortexes.
· Ordered supplies, stocked work areas and prepared materials for research purposes.
· Maintained clean and organized work area with adequate supplies and reagents.
· Adhered to all laboratory requirements and enforced compliance with regulations.
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