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.
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.
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.
Accomplished QUALITY CONTROL DIRECTOR within the Pharmaceutical and Medical Devices industries. Wide expertise in Quality Control Laboratory operations encompassing: Chemical, Microbiology, Stability, Analytical Transfer, Laboratory Instrumentation. Proven track record of exceeding goals in Compliance and Regulatory Affairs. Recognized Manager and Change Agent advancing procedures and technology and implementing Quality Systems in the workplace. Lean Six Sigma Green Belt Certified. Fluent in Spanish and 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.