Dynamic professional with over twenty (25) years of experience on the pharmaceutical industry. Hard worker, self-starter professional with strong leadership, technical and team work skills, highly oriented to meet plant goals and objectives. Strong knowledge of FDA Regulations, Consent Decree, Good Documentation Practices (GDP's), Good Manufacturing Practices (GMP's), DEA Regulations, ICH Guidelines, ISO9001/2008, and 21 CFR. Demonstrate expertise in mentoring within diverse cultures, creating and incorporating compliant courses of action which align with company and government agencies. Computer literate in Microsoft Windows Office, Word, Excel, PowerPoint, Outlook. Possess excellent written and verbal communication skills with strong technical writing abilities in Spanish and English. QA/QC professional with strong background handled product release, internal audits, annual product review, investigations, correctives and preventives actions, change controls, customer complaints, handled regulated and controlled materials, and laboratory testing such as raw material, in-process, finished products and stability. * Supports the Consent Decree Work Plan activities. * Solid experience in regulatory audits, analytical instrumentation and techniques, and validation activities within the Consumer Products, Pharmaceutical and Medical Device industries. * Adept at performing analytical audits and evaluations to effectively determine requirements and apply Lean concepts, 5S and Six Sigma skills to achieve them. Overview Sr. QA Specialist, QA Specialist, Stability Compliance Specialist, Quality Control Laboratory, Auditor, Customer/Employee Relations, ASQ Quality Auditor Academia, LIMS System, and SAP database. Reduced from 4 to 1.5 hours the revision cycle time of final disposition of Finish Goods packaging and from 2.5 to 1.0 hour the Bulk Transfers for Sub-Contractors. McNeil Quality Awards * ENCORE Awards in recognition of a special achievement. * Selected by PharmaBioServ and Industrial Association of PR as "Empleada Simbolo 2010". * Recognized by PharmaBioServ for dedication, commitment, and overall contribution to Scienza Labs success in 2010. * Managed over 15 Customers Audits during 2010 satisfactorily. * Create and maintains the Accelerated Stability Studies Table on weekly basis to using in the Integration Stability Meeting by R&D group. * Recognized for my contribution to successfully the Stability Program. * Supported the implementation of the SOP's Binder Master Index system * Released of 25 additional lots within the time frame requested by client. * Approval of FDA to lots under investigation in timely manner. * Recognized for my contribution to successfully complete the start-up of new product. * Completed the Stability analysis data entry project, one month early, in the new computerized system. * Reduced from 8 to 2 hours the analysis cycle time of packaging components Work Summary McNeil Healthcare Las Piedras, P.R 04/2013 - Present Sr. QA Specialist - Product Disposition Area Ensure product quality and customer satisfaction. Responsible of reviews manufacturing and packaging controlled documentation to ensure cGMP compliance throughout the manufacturing and packaging process. Performs final disposition of Finish goods packaging, Bulk transfer for Sub-Contractors and Raw Materials. Compiled records. Supports the Consent Decree Work Plan activities as required. Collects data and prepares metrics reports. Evaluates Change Controls, Special Protocols, Protocols, Investigations, and Laboratory test results. Supports internal/external audits as required. Provides data for Annual Product Review and performs QA destruction process management. Performs the final product approval signature for shipping and distribution through the electronic controlling system. Revised SOP" s. Prepared Certificates of Compliance for the product. Provides support to the Supervisor in projects, if needed. Prepare metrics for Quality Council meeting. Provides product batch records to the cGMP Expert to review and lot certification. Maintains effective verbal and written communication with all departments and at all levels of the Company. McNeil Healthcare Las Piedras, P.R 04/2012 - 04/2013 QA Specialist - Product Disposition Area Review batch records and gives disposition to the lot or material produced to ensure that all steps have been performed and verified where applicable. Ensure that all limits and specifications have been met and the raw materials and solutions have been tested and released. Supports the Consent Decree Work Plan activities as required. Evaluates Change Controls, Special Protocols, Protocols, Investigations, and Laboratory test results. Supports internal/external audits as required. Supports internal/external audits as required. Prepared Certificates of Compliance for the product. Performs status changes in the electronic control system according to the final disposition of the material or component. Performs QA destruction process management. PharmaBioServ Dorado, P.R 09/2006 - 04/2012 Sr. QA Specialist Responsible of enforcing and ensuring compliance with GLP's, company quality policies, procedures, Quality Manual, Quality Agreements, Validation Protocols, Test Methods and all regulatory compliance requirements. Ensures Quality System compliance and maintenance to latest industry practices trends. Reviews and maintains Quality Policy and Quality Manual updated. Manages Customer's Complaints and ensures adequate tracking and closing in a timely and responsible fashion exceed customers expectations. Review and approves Laboratory deviations/ Action Limits and reports and performs tracking and trending of the issues to QA and Operations Management. Approves Laboratory Certificate of Analysis, SOP's, Policies, Protocols, Investigation, CAPA and Change Controls. Performs Laboratory Internal Audits and ensures corrective actions are implemented as needed in response to quality issues or audit findings. Certify that analytical reports are completed, accurate, and within specifications, and proper authorization has occurred. Conduct and support laboratory audits performed by Customers and Regulatory Agencies. Ensures with compliance with new compendia changes (USP, EP, JP, etc), 21 CFR, ICH guidelines, and other applicable guidelines and regulations as applicable. Stability Compliance Specialist Maintains and coordinates documentation as required by the stability area such as Sampling Plan, Protocols, Method Specifications, History Records, Forms Control System, Calibration Records, and other documentation activities. Data verification and prepare the work scheduling. Conduct Accelerated Stability Studies for New Products. Performed Stability Investigation reports. Executed product Method Transfer Protocols. Prepared Monthly Report as needed by QA department. Support stability and compliance management on gathering data for reports as required. Train new personnel. Prepared and reviewed SOP. Assist in the review of documents for completeness and accuracy. Prepared Annual Product Review. Participates in the Change Controls implementation. Create, verifies and approved Protocols using LIMS System. Provide recommendations to support systems that continuously improve stability/process quality and reduce cost. Validation Specialist Coordinate and conduct internal laboratory audits. Participate in New Method / Product validations activities. Executed product Method Transfer Protocols. Evaluate and reviewer analytical data. VALEANT P.R. Humacao, P.R 02/2006 - 09/2006 Laboratory Analyst Perform laboratory testing of products according to USP and ISO9000/2001 guidelines. Assayed active ingredient, degradations and impurities by HPLC of in-process, finished and stability pharmaceutical products. Data verification and conduct internal laboratory audits. Participate in New Method/ Product validation activities. Performed Laboratory Investigation reports. Executed product Method Transfer Protocols. Data reviewer.

Highlights:

• 5S
• Communication Skills
• Complaints
• Compliance
• Computer Literate
• Consumer Products
• Corrective Actions
• Data Entry
• Database
• Distribution