- Successfully supervise 8-10 manufacturing employees in achieving production, quality and cost reduction goals.- Ensure production meets on-time scheduling goals; assisting on the production line as needed.- Perform Batch Record Review for content and accuracy, on a daily basis. - Write and revise standard operating procedures (SOPs) and work instructions to continually move towards more effective processes while reducing errors. - Participate in the design, execution, documentation of experiments, equipment, and process validations for new product scale-up, and improve operations quality.- Collaborate with R&D and Engineering in transferring new products and processes into production. Perform IQ/OQ/PQ to validate new equipment.- Maintain the production facilities, processes, equipment and documentation per cGMP and ISO 13485 requirements at all times.- Train personnel to comply with cGMP. - Responsible for focal reviews and support employee career development.- Act as a lead auditor in the internal audit program using ISO 13485.

-Lead coordinator in the implementation of a UDI compliant quality system to comply with recent UDI regulation (GUDID)-Support the internal audit program by leading internal audits, timely audit scheduling, and training to ensure regulatory compliance. Manage and conduct internal audits to assure compliance and continual improvement. ISO13485-Manage the NCR program and timely disposition of raw materials, in process, and final products.-Manage the CAPA program; review root cause analysis and proposed corrective actions; track the implementation and effectiveness of committed corrective and preventive actions.-Perform Batch Record Review for content and accuracy, on a daily basis as the lead RA representative - receiving inspection, manufacturing batch records (MBR) or device history records (DHR), component release and process validation

- Supervise and schedule manufacturing personnel to effectively meet increased batch requirements.- Review manufacturing batch records for content and accuracy.- Initiate process improvements leading to an improved manufacturing turn-time.- Revise standard operating procedures (SOP) and Work Instructions (WI) for efficiency and clarity.- Create and conduct training for equipment, assembly, and accountability.- Investigate and document non-conformance, including root cause and corrective action for CAPA.- Performed IQ/OQ/PQ to validate new equipment.

- Created prototypes and design support for medical devices and computer applications.- Performed industrial engraving based on detail specifications and technical drawings.- Operated and supervised operation of Nd:YAG and CO2 laser.- Provided technical customer support.- Implemented scheduling and process improvements for a reduced turn-time.

- Provided on-site technical support and completed TSRs (Technical Service Reports) including investigations and corrective actions.- Performed clinical in-house lab assays for medical clients.

- Supported process development and improvement through the standardization and validation of buffers and protein characterizations.- Performed supplier raw materials capability and stability studies.

- Manufactured buffers, reagents, extracts and solid phase protein coupling according to cGMP and GLP.- Developed SOPs for SDS PAGE and Western Blot and trained department personnel accordingly.- Participated as integral member of the Total Quality Management (TQM) teams.- Initiated improvements that significantly increased Luminol purification yields.

- Principal formulation developer of water dispersible granule product-process development, scale-up and manufacturing validation.- Principal developer of flowable product and troubleshooting quality issues for Japanese market.- Raw material screening/compatibility.

- Created Quality Control Department, supervised and trained 3 personnel.- Developed SOPs and Test Records- Quality testing and statistical analysis- Troubleshooting between Research, Formulation and Manufacturing departments regarding quality issues.

- Discovered and developed thin film alginate sheet formulation product.- Developed bulk polymer product.- Transfer and implementation of manufacturing specifications.- Product stability studies.- Bacteriastat and fungistat minimum inhibition testing.- Start initial stock cultures of bacteria and nematodes from field samples utilizing aseptic techniques.- Principal investigator of In-vivo and In-vitro population kinetics.

- Trained in advanced techniques such as scanning and transmission electron microscopy, PAGE, TLC, HPLC, radioisotope labeling and lipid extractions.- In-vitro aseptic culturing and in-vivo harvesting.- Whole blood separating to plasma and red cell.