
• Ensure sample integrity, including proper sample tracking, preparation, distribution, & storage.
• Visually Inspected finished products for quality and adherence to customer specifications.
• Adhere to work instructions, standard operation procedures, and product specifications at all times.
• Perform tests within CLIA/cGMP regulations and produce documentation in accordance with GDP.
• Set up and verified functionality of lab equipment.
• Inspected products and machines to maintain quality and efficiency.
• Reported on findings and made proactive and targeted recommendation to engineering and management.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Read worker logs, product processing procedures to verify records adhered to quality assurance specifications.
• Selected material quantities or processing methods needed to achieve efficient production.
• Prepared reports and technical documentation of day-to-day production processes.
• Scheduled preventive and predictive maintenance actions based on failure analysis.
• Monitored employee actions for adherence to safety procedures.
• Evaluated employee performance and equipment organization to assess and improve plant operations.
• Prepared standard operating procedures, manufacturing batch records and productivity reports.
• Performed preventative and corrective maintenance on Autoclave & agitators/mixers
• Delta V. and Water for Injection (WFI) trained
• Performs post-formulation processing such as product cutting, inspection, defect identification and packaging in order to produce the finished product. All work streams include responsibility in the setup, operation & cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 7 areas and require proper Clean Room gowning.
• Performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations), Standard Operating Procedures (SOP’s) and Health and Safety requirements.
• Operate in a team environment focused on daily milestones and quality throughput.
• Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
• Responsible for the cross linking, cutting and packaging of the product in its finished goods form, which includes performing visual product and component inspections to identify and remove defects.
• Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
• Handled chemicals such as Sodium Hydroxide, Chloroform, Methanol, Ethanol, PBS (Phosphate Buffate Solution), Isopropyl.. etc
• Flesher machine
• Transport Chemical barrels
• Time sensitive SOP
• Handling of animal skins
• Training simulation for processing
• Washing, disposing contaminated containers
• Sanitizing stations
• Safety, Bio hazard, GDP trained
• Lyo machine
• Worked closely with engineers and scientists as part of a fast-moving, cross-functional R&D team
• Active material evaluation and selection; Cathode electrode formulation and specification
• Cell measurement and data analysis to identify critical factors limiting life and/or performance; cost optimization.
• Evaluate active materials to meet product requirements and R&D objectives
• Build cells and analyze data to quantitatively measure and compare cell performance
• Apply diagnostics to investigate cell reactions conduct failure mode analysis to identify root causes and generate novel solutions
• Support the product and process development teams in material evaluation, cell building, cell testing, and data analysis
• Champion for environmental health and safety