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.
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.
QUALITY CONTROL AND ASSURANCE ANALYST and CERTIFIED LEAN SIX SIGMA YELLOW BELT professional with experience in the pharmaceutical industry within a manufacturing environment. Knowledgeable in laboratory instruments such as: HPLC, FTIR, UV,CFA, pH meter, dissolution baths, disintegrator, water activity tester, TOC analyzer, vacuum oven, and analytical and micro balances. Qualitative and quantitative evaluation of in-process and finished products, chemicals, raw materials and packaging components. Testing in compliance with Safety, GMPs and documentation requirements. Expertise using Empower, GLims and laboratory instruments. Laboratory Excellence culture. Bilingual in English and Spanish.
With fifteen years of experience in the pharmaceutical industry, including five years in the supervisory field. Proven professional with focus on quality and efficiency. Vast knowledge in instrumentation and solid dosage manufacturing equipment and processes such as: mixing, granulation, drying, compression, and coating. Knowledge of solid dosage packaging equipment and processes (filling, capping, induction sealing, labeling, banding, and blistering). Expertise in safety, GMPs, documentation, KAIZEN process, investigations and CAPA (corrective and preventive actions) systems. Works well under pressure and teamwork oriented. Strong analytical skills and root cause analysis techniques. Computer literacy and proficient in Microsoft Office, AutoCAD, CALpro, Track Wise, and Maximo.
Highly qualified Biologist with more than 15 years of experience in the Pharmaceutical and Manufacturing industries. Experience working as Quality Assurance and Compliance Officer. Expertise in Safety and Security, GMP’s, documentations, FDA audits and regulations, change controls, performance investigations, release in Raw Materials, bulks in process, finished products, manufacturing and packaging batch records review. Broad knowledge of Quality Policies and Standards. ISO 9002 Certified. Team work oriented. Knowledgeable in Trackwise System. Fully bilingual in Spanish and English.
Supply Chain & Logistics Supervisor within the medical devices/ pharmaceutical and electric manufacturing industries. Wide expertise in production & demand planning, forecasting, procurement, warehousing, logistics, key customer management, returned goods' management for internal and external customers, including the Caribbean outsourcing and distribution, negotiation, and customer service. Proficient in Microsoft Office and AS400/ JDE. Proficient in English.
Human Resources Executive with over 20 years of experience in multinational corporations with customer focus and strategic business partnering. Effective written, verbal communication and presentation skills. Highly confidential and self-motivated team contributor. Vast knowledge of federal and local labor legislation. Excellent interpersonal relationship skills, ability to foster strong working relationships with managerial staff, peers, and business partners. Demonstrated ability to motivate staff to maximize ability and productivity, and control cost through the most effective uses of manpower and available resources. Languages: English & Spanish.
Accomplished manager with 7 years of experience in marketing, merchandising and replenishment in the retail industry. Broad knowledge and proven success in delivering results in a competitive market. Excellent communication and analytical skills, strategic thinker, customer service and teamwork oriented.