Advanced Quality Engineering and Quality Operations / Compliance Management • New Product Development • Process Excellence Engineering • Six Sigma Methodologies • DMAIC and DMADV • Supplier Quality Assurance Management • FDA/ISO Subject Matter Expert• cGMPs • CAPA • Risk Management • EHS.
Expertise in the Medical Device / Pharmaceutical industry with extensive knowledge in the FDA Code of Federal Regulations and ISO/ European Standards. New Product Development/Transfer (Design Excellence), Combination Products, Process Excellence (Six Sigma Methodology), and Total Quality Management (TQM) Development tools.
Business Development Analyst with over 7 years of experience in a distribution environment and demonstrated history of working in the industries of food and beverage, medical products and household products. Skilled in Forecasting, Data analysis, Customer Service, Sales, Logistics Management, KPI Reporting, and Purchasing. Creative, self-learner, efficient and diligent problem solver who is motivated to exceed position requirements. Areas of skill include: Specialized knowledge in technology and applications including SAP, Retail Link, Market Track, all Windows OS, Mac OS, Microsoft Office, Acrobat Professional, MS Project, among others. Fully Bilingual English and Spanish.
Editor and Journalist with over 11 years of experience in both print and digital media. Team oriented. Excellent communication and interpersonal skills. Computer literate Windows, Mac, MS Word, PowerPoint, Excel, Photoshop, HTML, Illustrator, FTP (Filezilla), InSite and Adobe Viewer. Bilingual in Spanish and English.
Over 15 years working in Chemical Laboratory, Packaging, Visual Inspection, Parenteral manufacturing and Operations. In depth experience developing SOPs, Change Controls and Manufacturing Investigations. Hands on experience auditing manufacturing areas. Experienced with regulatory agencies, 21 CFR Part 11, cGMPs, OSHA and Lean Manufacturing. Responsible, self-starter highly organized, flexible with proven leadership skills and management/supervisory skills. Capable of managing multiple tasks in a high pressure environment with minimum supervision. Quality and teamwork oriented with excellence interpersonal and communication skills. Ability to influence and motivate others. Computer literate on MS Office, Visio, SAP, TrackWise, MES (Electronic Batch Records), Kronos/ADP. Bilingual in English and Spanish.
Skillful and dedicated project coordinator professional with extensive experience in the coordination, planning, and support of daily operational and administrative functions. Demonstrated leadership skills driving team to meet deadlines, increase productivity, reduce operational costs, maximize resources utilization, and optimize fulfillment of organizational processes. Adept at developing and maintaining detailed administrative and procedural processes that reduce redundancy, improve accuracy and efficiency, and achieve organizational objectives. Key team player, providing support to executive-level staff, subordinates, peers, and support areas including strategic team, marketing, ISD, and replenishment. Proficient in Microsoft office system, Microsoft Visio®, Microsoft Project Manager, Microsoft Windows® operating system, Retail Link, Host, Outlook, Wire, Type speed of 90 wpm with complete accuracy.
Highly qualified QA and QC professional with 5 years of experience in pharmaceutical industry. Knowledgeable analyzing Finished Good Products, Raw Material, Stabilities, Audits calibration equipment’s, manufacturing/packaging process and validation protocols and process. Vast knowledge in laboratory instruments such as: HPLC, PH Meter, FTIR, Disintegrator, Autoclave, Microscope, micropipettes, shaker, balance, SAS (microbial air sampler), particulate counter, RCS, Incubators and centrifuge and LIMS System. Testing experience in compliance with safety, cGMP's, Good Laboratories Practices (GLP), SOP, Good Documentation Practices (GDP) and documentation requirements. Teamwork oriented and good communications skills. Laboratory Excellence culture. Fully bilingual (Spanish and English).
Quality Systems/Compliance/Production Specialist with extensive experience in the Pharmaceutical and Manufactory industry. Expertise performing internal audits and support regulatory audits, customer complaint’s investigations and production investigations, Annual Product Review (APR) preparation and evaluation, provides management visibility to product and/or process trends, manages change controls and corrective and preventive actions (CAPA). Production Leader with experience in personnel management, schedule preparation, schedule attainment, Overall Equipment Effectiveness (OEE) and process improvement. Expert in regulatory requirements, audit programs (internal and external), investigations, complaints, CAPA management, trends evaluation, FMEA, graphs preparation, statistical analysis, business process improvement, validations and cGMP. Strong problem solving, communication skills and self-oriented in setting priorities. Excellent computer skill and full knowledge in computer programs such as: MS Standard, Minitab, SAP, LIMS, PQMS, Trackwise, DIGA System, OTC Doc System.
Productive Supply Chain Professional with vast experience in the Pharmaceutical industry. Broad knowledge of GMPs and Pharmaceutical Manufacturing regulations. Extensive experience working in: Purchasing, Procurement, Inventory Management, Planning Operations & Logistics. Solid knowledge creating Inbound Delivery, maintain records, interacts with Warehouse department, purchase of Raw Materials and Packaging Components, inventory management, master scheduling, material requirements, planning, production order processing and transaction audits. Capable in managing assigned simultaneous projects and achieving deadlines accordingly. Excellent problem solving, communications and analytical skills. Customer Service and teamwork Oriented. Basic knowledge with Lean principles such as Kan-Ban & Kaizen. Fully bilingual (Spanish and English). Computer proficient: Word, Excel, Power Point, ARIBA, People Software, & SAP.
Strategic Supply Chain and Logistic Operation with wide experience in the retail industry within global companies. Good combination of technical, functional and managerial skills. Broad knowledge in improvements methodologies such as Six-Sigma, Manufacturing Production Operations, materials management, production control, quality, regulatory experience, deployment of key business strategies and initiatives. Strong Interest Inventory Profile, Leadership Assessment Surveys, Brickman Method, Caliper, PDI PROFILOR, 360 Leadership Survey, OSHA USDA FDA and ADA, Merger & Acquisition. Excellent communication skills. Adapts well to change. Has successfully worked on multiple industries in diverse international assignments. Fully bilingual.
Professional Mechanical Engineer with five years of experience as Quality Compliance Officer, GxP Manufacturing Leader, Project Management (PM) and Computer Systems Validation (CSV) in the Pharmaceutical and Manufacturing industry. Strong knowledge in manufacturing process, packaging, facilities/utilities, Solid Dosage and OTC areas. Expertise with current Good Manufacturing Practices (cGMP) and Regulations. Knowledge and experience with CSV Remediation and Computerized System Retirement Project Management areas. Professionally oriented in the areas of Audit, Compliance, Operations and Research. Computer literate in: Microsoft Office (Excel, Power Point, etc), Solid Works, AutoCAD, Track Wise, Consumer Relationship Tracking Systems (CRTS). Intermediate knowledge in English.