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Anabel Ortiz 2016


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Anabel Ortiz 2016

  1. 1. Anabel Ortiz 131 Church Rd Apt. 5J North Wales PA, 19454 845-803-4163 Email: 18 years of experience in the pharmaceutical field in the quality laboratory area, regulatory compliance and Viral Vaccine Manufacturing. Training provider for new and existing employees in cGMPs, SOPs, Methods, Safety, basic laboratory skills and computerized systems like Empower, LIMS and ISOtrain. Preparation of Supplier Specification Sheets, Compliance audits, creation of SOPs and updates. Laboratory expertise including testing, instrumentation and certification of laboratory personnel. Perform all functions required to produce vaccines. Relevant Experience 2010-Present Bio-Technician-Level 2 Merck & CO., Inc. West Point PA Following the appropriate SOPs and other pertinent documentation, perform all functions required to produce vaccines. Document all work according to proper cGMP documentation practices and perform review of manufacturing documentation. Clean, assemble, operate, disassemble, maintain, trouble shoot and initiate corrective actions as required to meet production schedules. Perform sampling supporting the manufacturing and validation processes for current process as well as developmental work for new products/processes as required. Ability to perform aseptic/sterile operations. Use of safety and personal protective equipment and clothing such as safety glasses, gowns, and respirators as listed in departmental SOPs, etc. Work with the pooling, sonication and filtration skid during set up and processes. CIP systems (automated and manual). Material handling equipment such as freezers (-70ºC),Shell Freezers, Thaw baths, Sartocheck, and pumps. Perform environmental monitoring such as rodac surface testing and using equipments such as SMA, and particle counters. Used computer systems such as MES (electronic batch records), SAP (Comet), HanDEL, LIMS CanDB, DeltaV, Word and Excel. 2007-2009 QA Trainer III, Regulatory Compliance Department Watson Laboratories, Carmel NY 2005-2007 Laboratory Trainer II Watson Laboratories, Humacao PR Offered New Employee Orientation (NEO) training to all company employees. Trained personnel on the history of the FDA, the code of federal regulations (CFR) and its different chapters including electronic signatures as well as Good Manufacturing Practices (cGMP). Provided training on proper cGMP documentation practices and its importance. Explanation of the repercussions of not following cGMPs including 483s, warning letters, consent decrees, etc. Offered and prepared cGMP trainings and their audiovisual materials. Created, maintained and updated lesson plans, curricula used to orient new hires or train existing personnel. Created new modules and updated existing ones as well as included employees in modules in
  2. 2. accordance with their positions. Trained new employees, as needed for corrective actions, preventive measures and safety issues. Issued training documents and entered them into the training database ISOtrain. Offered individual training plans. Trained new hires in laboratory basic skills, analyses, procedures and equipments. Performed certifications and re-certifications of laboratory personnel on various equipments and techniques. Performed peer review and GLP auditing of certification data including logbook entries. Trained employees in computerized systems like Empower and LIMS (serve as SME and help all employees who encounter problems). Provided Respirator Fit Tests. Prepared Supplier Specification Sheets (SSS). Gap Analysis of Corporate Quality Policies vs. Internal SOPs. Wrote and updated SOPs and GTPs (General Testing Procedures). Company wide cGMP walkthroughs and Compliance audits. 1997-2005 Laboratory Chemist III Watson Laboratories, Humacao PR Performed analysis on intermediate and finished products. Knowledge of laboratory methods and analyses (Assay, Content Uniformity, Impurities/Degradants, Dissolution, ID, TLC, Water Content and Friability Test). Operated general analytical instruments during routine testing (HPLC, UV-VIS, IR Spectrophotometer, Karl Fisher, pH meters, laboratory balances and Dissolution baths). Maintained appropriate documentation as required by relevant SOPs. Participated in troubleshooting of analytical methods and laboratory equipment. Data auditing (perform peer review of other chemist’s work). Equipment logbooks and preparation logbooks GLP auditing. Method Transfers. Outside trainings (other sites). Wrote laboratory investigations. Received and controlled laboratory samples. Stability Area (pulled and entered samples into the stability chambers, trend analysis, tested stability samples, data auditing). Raw Material Area (LOD, ROI, pH reading, Titration, Heavy Metals, Particle Size, Bulk and Tapped Density, TLC ). Analysis of Controlled Substances. Compliance with DEA and site requirements regarding the handling, use and disposal of Controlled Substances. Analysis of Oral Contraceptives. Education BS in Chemistry, Turabo University, Caguas Puerto Rico Associate Degree in Chemistry, Technologic Institute of Puerto Rico Other Experience Empower Software, LIMS, Millennium 32, Class VP, Manual Integrators. Windows Word, Excel and PowerPoint. GLP, cGMP, Train the Trainer, ISOtrain and HPLC Troubleshooting. Fully Bilingual (English and Spanish).