Process and maintain mesenchymal stem cell cultures isolated from dental pulp under GTP guidelines. Experience with Lab Management Systems and GDP. Revise and create SOPs and other controlled documents (customer forms). Train new employees on process and technique. Maintain training logs of staff. Review quality records and logs. Experience with Document Management, Change Control and CAPA procedures. Knowledgeable with FDA and HTA/EU regulations and experienced as host and most… Show more Process and maintain mesenchymal stem cell cultures isolated from dental pulp under GTP guidelines. Experience with Lab Management Systems and GDP. Revise and create SOPs and other controlled documents (customer forms). Train new employees on process and technique. Maintain training logs of staff. Review quality records and logs. Experience with Document Management, Change Control and CAPA procedures. Knowledgeable with FDA and HTA/EU regulations and experienced as host and most responsible person for FDA inspections. Show less

Document Managment within a GMP Quality Management System in accordance with Standard Operating Procedures (SOPS) and Work Instructions (WIs).Created, revised and edited SOPs and other controlled documentation.Managed the archive, retention, and destruction of documentation in accordance with requirements.Managed Non-conformance, Change Control and CAPAs (Corrective Actions Preventative Actions) in accordance with SOPs and WIs.Received client-specific training on Montrium… Show more Document Managment within a GMP Quality Management System in accordance with Standard Operating Procedures (SOPS) and Work Instructions (WIs).Created, revised and edited SOPs and other controlled documentation.Managed the archive, retention, and destruction of documentation in accordance with requirements.Managed Non-conformance, Change Control and CAPAs (Corrective Actions Preventative Actions) in accordance with SOPs and WIs.Received client-specific training on Montrium Quality Connect product.Prepared SharePoint site of Quality Management System (QMS) documents for audit support.Train staff to applicable procedures including annual GMP training, Good Documentation Practices (GDP), etc.Incorporated the use of Microsoft FORMS to include quizzes to ensure read and understand comprehension in our remote training and working environment.Transfer documents to new approved templatesPerform other duties and cross training, as assigned, such as reviewing CMO Master Batch Records. Show less

Support Manufacturing in the purification of plasma into therapeutic proteins. Complete special projects that range from product failure investigations, yield improvement, CAPAs to developing new processes.

- Participated in cancer research projects- Sustained mammalian cancer cell lines and maintained mouse colony- Organized the start-up of a new lab in August 1999- Managed inventory of lab supplies and equipment- Monitored laboratory safety as Safety Officer- Trained new lab technicians on protein detection techniques

- Synthesized DNA oligonucleotide including degenerate, tagged and modified base DNA oligonucleotide for use in various research projects using Applied Biosystems DNA/RNA Synthesizers- Analyzed oligonucleotide using Capillary Electrophoresis for quality control- Purified DNA oligonucleotide using reverse-phase HPLC