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.
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.
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.
Licensed Chemist with vast experience within the Pharmaceutical industry. Experience working in the Quality Control and Quality Assurance areas for world class multinational pharmaceutical companies. Possess diversify knowledge in analytical testing methods/method transfer/protocols/reports, products release, Annual Product Review, approval and certification of batch record, writing and revising operating procedures, laboratory assessment, EU/JP/US pharmacopeias, technical writing, FDA and Safety regulations, GMP’s, SOP’s, and GLP’s. Demonstrate leadership and analytical skills, the ability to manage priorities in a fast paced regulated environment, as well as effective communication skills and working relationships with internal/external customers. Familiar with LEAN principles, strategies and techniques and proficient with laboratory equipment and computerized systems: MS Office, G-LIMS, Empower and SAP. Fully bilingual.
A hardworking professional with eleven years of experience within the Pharmaceutical industry and manufacturing environment. Full knowledge of 21CFR, GMP’s, Standard Operating Procedures (SOP’s), Technical Operating Procedures (TOP’s), CAPA System, Non Conformance Report (NCR), TrackWise System, SAP, Ensure, STARLIMS, Timesaver, Lean Manufacturing Methodologies, Kaizen, OSHA, Emergency Management. Yellow Belt Lean Six Sigma Certified. Capable of quick transitions and endowed with a strong sense of leadership that has proven successful involvement within the teams. Fully bilingual.
Quality Assurance Director with vast experience within the Pharmaceutical and Manufacturing industry. Experience working in Medical Devices, Quality Assurance, Management and Regulatory Affairs. Broad knowledge of cGMP’s and Pharmaceutical Manufacturing testing and regulations. Lead in FDA, ISO, Australian, European Medical Agency and customer audits and response letters. Extensive experience in product Reviews, complaints investigations, validation protocols, Document Control & Retains, CAPAs, raw materials and finished goods. Fully bilingual in English and Spanish.