Quality Assurance - Manufacturing Resume Search
Quality Assurance - Manufacturing Resume Search
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Quality Assurance Resume


Desired Industry: Manufacturing SpiderID: 81371
Desired Job Location: Orlando, Florida Date Posted: 8/27/2018
Type of Position: Full-Time Permanent Availability Date: 09-03-2018
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel:
Highest Degree Attained: Masters Willing to Relocate:


Experience:
Quality Manager & EHS Coordinator, 08/2017 to 08/2018
Cascade Designs Inc. – Reno, NV
• Managed the Quality Assurance and Environmental, Health & Safety functions of the QA and Safety Division
• Developed, implemented and managed QA, product liability and employee safety program in accordance with local, state, and federal requirements of the production of reliable outdoor products
• Managed the risk management process at Cascade Designs Nevada (CDN) LLC
• Ensured policies, procedures and actions are in place to help the company achieve excellent quality and champion continuous improvement
• Supported Product Development by actively participating in the development of Product Development processes and ensuring Quality strategies and considerations are provided during development processes and during design review and ensuring commitments are adhered to
• Review and approve Certificates of Analysis and/or Certificates of Test
• Managed effectively the Environmental, Health & Safety program
• Managed the activity in product safety incidents and ensured timely and effective resolution. OSHA 300 & 300A Log and Workers' Compensation documentation handling.
• Locate, review, understand and be able to effectively interpret and communicate safety/health/environmental regulations such as administrated by OSHA, EPA, NFPA and other governmental agencies to ensure company-wide compliance
• Sponsored the Safety Committee & Emergency Response Teams, providing them the guidance, structure and resources needed to meet the needs of local, state and federal laws and regulations
• Managed an effective QA & Safety department staff
• Hired, developed, motivated and inspired employees to effectively meet or exceed departmental and company needs and objectives
• Supervised inspectors and technicians to ensure final output is satisfactory
• Reviewed and approved time cards, vacation requests and ensured compliance with company attendance standards
• Interacted on a regular basis with Executive, Senior Staff, and the management team at CDN
Engineer/ Scientist II, QC, 06/2016 to 08/2017
Thermo Fisher Scientific – Sparks, NV
• Ensured product quality throughout every stage of operations. This include inspection of the products when received and following up as appropriate when products are rejected
• Ensured that the inventory meet company quality standards
• Performed the corresponding analysis of melting point (MP), refractive index (RI), pH, identification and appearance
• Evaluated receipts of chemicals and precious metals as they are received into the inventory database
• Validated and calibrated Laboratory Equipment; Implemented new analytical process methods
• Visually inspected products that are received into quality control status
• Examined chemical product reports and file the appropriate paperwork
• Completed daily certifications of analysis ratings for all receiving
• Generated the SOPs related to the operational and quality areas
• Participated in the quality control cycle count
• Address customer complaints in a timely manner; Assisted services with inquiries of product quality
• Reviewed and approved Certificates of Analysis and/or Certificates of Test
QA II/ Customer Compliance Coordinator, 11/2011 to 05/2016
Baxter Healthcare – Guayama, Puerto Rico
• Monitored multiple databases to keep on track and coordinated all activities to complete the complaints investigation in a timely manner
• Performed Non-conformance investigations and Corrective Action Preventive Action (CAPA) handling
• Evaluated for Field Alert Report (FAR) Submissions; Generated Risk Assessment for Distributed Product
• New Drug Applications (NDA), ANDA and Supplements
• Conducted and Assisted the Internal Audit Program; More than 12 years of experience conducting Internal Audits
• Outstanding performance driven on Batch Record Review (MBR) and Retained Sample evaluations as part of the complaint investigations and to assure compliance before release lots
• Established and follow-up actions of complaint investigations and implementation of corrective actions
• Maintained open line of communication with the customers to assure proper flow of information
• Supervised personnel on behalf of the area manager
• Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
Professor of Organic Chemistry & Laboratory, 01/2010 to 02/2011
Universidad Interamericana de Puerto Rico – Guayama, Puerto Rico
• Organic Chemistry & Laboratory Professor
• Organized and prepared educational material for classes according to curriculum
• Evaluated Exams and Laboratory Reports as part of the Natural Science & Technology Department
Stability Coordinator and Release Specialist, 03/2006 to 10/2011
Baxter Healthcare – Guayama, Puerto Rico
• Coordinated the stability program for the site assuring lots are tested and reports are issued in accordance to their schedules and stability protocols
• Supported the development, implementation, and improvement of corporate quality systems that support the change control process of drug products/ clinical trials programs
• Increased compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
• Reviewed and approved product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
• Maintained the Stability Program of the anesthetic products; Performed stability report and analyzed stability data for significant trend
• Assured stability incubators are working in optimal conditions and within operating range
• Worked and supported the pharmaceutical quality control, analytical methods, cleaning method development, method validation and regulatory interactions
• Generated the Annual Product Review (APR). This document was mentioned as a "Best Practice" as part of cGMP Audit.
• Conducted the Annual Good Manufacturing Practices (GMP) trainings and the GMP training to new hires, etc.
• Generated the Company Site Master File (SMF)
• Revised and maintained procedures under ISO/FDA standard regulatory compliance
• Qualified the "REES CENTRON" Monitoring System Upgrade (for the Stability Incubators monitoring) in compliance with Life Cycle requirements
Quality Control Inspector, 03/2004 to 03/2006
Baxter Healthcare – Guayama, Puerto Rico
• Inspected components and raw materials used in the plant during their arrival, to ensure that all materials used meet specifications
• Inspected the production line of anesthetic product fill and pack area to insure the quality of the process
• Coordinated protocols and gave support to validation area; Completed precise measurements using special tools
Laboratory Chemist Analyst, 02/2001 to 02/2004
Baxter Healthcare – Guayama, Puerto Rico
• Performed laboratory analysis such as: TSS, S.S., GC, pH, Metals in Atomic Absorption & ICP, Oil and Grease, Fluoride, Wet Chem, Gravimetric analysis, Acid/Base titrations, Conductivity, UV-Vis, FT-IR, Karl Fisher Coulometric Titration, Densimeter, Viscometer, Refractometer, Extractions/ clean-up methods, Standardization, Standard (Stock & working) preparation.
• Performed System Suitability verification; LIMS handling; EPA Standard Methods handling
• Calibrated Laboratory Equipment; Verified data integrity and accuracy; GLP
Chemical Operator, 11/1999 to 02/2001
Ohmeda Caribe Puerto Rico – Guayama, Puerto Rico
• Monitored Chemical Reactions and distillations; fill out legal documents, Material Bill Records
• Transferred product, performed mass balance calculations, etc.
• Identified Improvement Opportunities during the routine "Gemba Walks"
• cGMP, MBR, SOP and Product Specification handling; Tested products or subassemblies for functionality or quality


Education:
Master of Science: Science- Chemistry (2009), Thesis defended
Pontificia Universidad Catσlica de Puerto Rico - Ponce, PR
Bachelor of Science: Chemical Technology
Universidad Interamericana de Puerto Rico - Guayama, PR


Affiliations:
Member of "Colegio de Quνmicos de Puerto Rico" (CQPR)
Member of American Society for Quality (ASQ)


Skills:
Results oriented, Analytical Chemistry, Client focused- relation, Computer proficient, Report Generation-Analysis, Statistical analysis skills, Customer satisfaction, Internal Audit, Project Management, Critical thinking, CAPA/ Investigations, Quality Inspection/ AQL, cGMP/ GLP, REES, LIMS, Minitab, Wet Chemistry, HPLC, GC, ICP, AA, TrackWise, IsoTrain, FMEA, EPA/ USP, Team leadership, Quality Control, Sense of urgency
Detail oriented, analytical, data driven, and ability to solve complex problems
Customer focused and able to interpret and translate customer needs into value added solutions
Demonstrates a sense of urgency, optimism and a “can do” attitude
Ability to build relationships across different business functions and business units
Passionate about challenges, problem solving, and learning new things
Authentic, transparent and leads by example, holding self and others accountable


Additional Information:
• License of Chemist, by Chemist Examination Board of Puerto Rico State Department
• Safety and Health Practitioner Certificate
• Jury of the Competency of You Be the Chemist Challenge (YBTC) 2016 sponsored by Dow Agro Science and Chemical Educational Foundation (CEF)
• Delegated of Academy of the Chemist Professional Organization of the Chemist College of Puerto Rico
• Recognition by Baxter Global Service for 75 hours of Volunteerism
• Recognition as Baxter Healthcare 2009 Symbol Employee
• Recognition in the College Board National Hispanic Scholar Award Competition for outstanding Hispanic students, where obtained an Honorific Award for competing and obtaining a highest score



Reference:
Available upon request.


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