Grisel Garcia Email & Phone Number

Madison, Wisconsin, United States

Madison, Wisconsin, United States

Wide range of task that include: drive investigations, CAPA and Change managements, internal/external auditing, and direct involvement and collaboration with the operations, technical operations, Engineering, and Management group. Manage Deviation and NCMRs from initiation to disposition. Manage CAPA creation and ensure adequate effectiveness. Perform trending of Quality Systems to support FDA and Management Reviews. Coaching and mentoring others in regards to QMS and Quality Culture. Present investigations and deliver disposition recommendations. Improve existing procedures to align with cGMP and regulatory requirements. Interpret and properly apply all applicable regulatory requirements. Perform and lead Risk Cause Analysis (RCAs) through cross functional team involvement. Perform Annual Product Review, Management Review and Annual Data Integrity analysis.

Madison, Wisconsin, United States

Responsible for supporting and improving the current Quality System at Stratatech Facility. Drive investigations and manage deviations and NCMRs from initiation to disposition. Manage CAPA creation and ensure adequate effectiveness. Perform internal and external audits of systems and suppliers. Perform trending of Quality Systems to support FDA and Management Reviews. Coaching and mentoring others in regard to QMS and Quality Culture. Present investigations and deliver disposition recommendations. Interpret and properly apply all applicable regulatory requirements. Manage Supplier Quality. Perform and lead RCAs through cross functional team involvement. Review procedures and specifications.

Puerto Rico Area

Manage and oversee the collections process to ensure timely payment from customers (Experience managing portfolios of $18+ million). Responsible for collection efforts on key accounts. Manage a collections team of 8+ Account Analysts. Responsibilities include hiring, motivating, training, performance management and monitoring collectors to achieve collection goals. Responsibilities also include establishing credit policies for customers and overseeing the collections process and providing scheduled and ad hoc financial reports to forecast short-term and long-term cash flow. This information is presented to executives and upper management officials in a regular basis. Review daily delinquency reports with Account Analysts. Oversee the posting of customer payments, payment reconciliation and research/resolve cash application issues. Enforce adherence to control requirements.

Puerto Rico Area

Responsible for project implementation related to Global Account and multidiscipline solutions project. Support in the implementation of new Project Management Program to implement a local PMO Office in accordance with Ricoh Methodology Framework. Projects encompass sales from $30k throughout $1.5M. Also, responsible for the maintenance of the Total Quality Company initiatives, including the ISO 9001, ISO 14001 and ISO 27001 programs. This comprises the readiness for Internal and External audits for the three ISO programs. As part of the ISO 14001 certification, monitored and maintained all the requirements related to the applicable federal and local regulations. Accountable for the management of Quality System and developed methodologies and standards to measure the success of the Quality programs. As part of quality program, managed the CAPA system and developed the annual communication plan and pertinent trainings. Also heavily involved and responsible for the planning and promotion of employee’s community activities and services in order to promote and create environmental conservation awareness.

Puerto Rico

Responsible for the review and approval of investigations related Out of Calibration/Unscheduled Maintenance Incident. Additionally, performed the evaluation of Non-conformances to determine further corrective/preventive actions and related trend analysis for complementary monitoring of the corresponding CAPA trigger. Responsible for the assessment/review of the cleaning process requirements including: cleaning schedule evaluation, testing results, graphs analysis etc., in order to determine whether or not a cleaning validation was required. The cleaning evaluation comprise the assessment a Cleaning validation gap analysis against standards requirements or recognized standards changes applicable for Implantable Class III product. In addition, the responsibilities encompassed the completion of CAPA’s assigned in an effectively and on timely manner in accordance with standard lead-times of the Implementation Phase and the completion of the VOE Phase. Implemented preventive actions according to the established action plans. Accountable for the Suppliers Performance; this included, but was not limited to, the evaluation of corrective actions requirements through SCARs system. When required, facilitated communication to improve yield. Monitored and evaluate all laboratory Out of Specifications related to DI Water System control monitoring and delineated the path forward to release the system for production activities.

Puerto Rico Area

Responsible for the development, implementation and maintenance of the Total Quality Company initiatives, including the programs for ISO 9001, ISO 14001 and ISO 27001. This comprised the readiness for Internal and External audits for the three ISO programs. As part of the ISO 14001 certification, monitored and maintained all the requirements related to the applicable federal and local regulations. Accountable for the management of Quality System and developing methodologies and standards to measure the success of the Quality programsCollaborated with Latin-American Region Management in the implementation of quality initiative and new initiative projects. As Project Leader, I implemented and monitored all the new corporate initiatives in order to meet milestone and deadlines.

Puerto Rico

Provided support to Corporate QA in reviewing and approving Protocols and SDLC Corporate documents. Supported and assured a Part 11 “inspection ready” state at the PR Site. Promoted and coordinated a monthly meeting with the affected departments to discuss the VMP attainment and activities. Supported and facilitated the Engineering Capital Project, Equipment Qualifications, Computer Validations project timelines and objectives, including the approval of documents related to the projects (Protocols (IOQ, PQ), Change Controls, URS, FRS, VMP, among others). Evaluated the feasibility to facilitate and support the initiatives to establish an automatic tracking system for investigations by searching the available alternatives in the market, performing project plan and an estimated budget. Review and approval of facilities, utilities, equipment and drawings changes through Change Control System

Puerto Rico

Acted as liaison between Manufacturing Area and Quality, Engineering, Pharmaceutical Technology and Administration. Responsible for the evaluation of regulatory documentation such as manufacturing records, qualification protocols (IQ/OQ/PQ), and SOP’s (Operational and Computerized System Administration). Supported the implementation of MRP II and CVS Site’s initiative, and improvement of product yield. Supported, monitor and generated metrics related to CAPA’s and Change Control progress. Supervised 4 employees during the equipment installation qualification and troubleshooting activities. In charge of the Computerized System Administration for the following manufacturing equipments: Glatt Fluid Bed Dryer, MG2 Encapsulator machines, Fette Tablet Press, Bosch KKE Checkweigher and Accela Cota). Supported site transfer projects focused on manufacturing requirements from the operational standpoint. Provided technical support to the resolution of operational area investigations (Process/Packaging).

Puerto Rico

Responsible for the development and execution of Installation and Operation Qualification Protocols for BOC Edwards Filling Line (Vial Washer, Depyrogenation Tunnel and Inline Continuous Liquid Filler) for aseptic area. In charge of the computer System Qualification (CSQ) assessment, CSQ Protocol Development and execution for the BOC Edwards Filling Line. Generated PQ Protocol for Depyrogenation Tunnel. Prepared the Master Validation Plan for 500L Process Tanks. Reviewed the User Requirement, Specification Document and SOP’s related to the process equipment.

Puerto Rico

Supervised the activities of process equipment validation of 10 contractors in the development and execution of qualification protocols for manufacturing equipment. Reviewed qualification protocols, engineering studies, commissioning reports, deviation report and summary reports for: Fluid Bed Dryers, Tablet Press Machines, Coating Machine among others. Responsible for the development and execution of IQ/OQ qualification protocols and engineering Studies of Solution Tanks, valves and Transference pumps (Waukesha, Jabsco, Zenith) for the Solution Preparation Systems of the Glatt Fluid Bed Dryer, Tri-blenders, Accela-cota Coating Machine, among others.

Puerto Rico

Responsible for the implementation and direction of productivity improvement projects based on Six Sigma philosophy for this coil production manufacturer. Identify problem areas and deficiencies through the use of Design of Experiment (DOE), Cause and Effect Matrix, Failure Mode and Effect Analysis (FMEA), among other utilities; assess processes; develop improvement programs; generate cost estimates and return on investment levels to ensure effective and timely results. Identified causes for scrap and product rejections; established controls and adjustments. Selected and designed equipment and materials for layout and control projects such as line balancing (KanBan), inventory and work-in-process control (WIP). Project management activities included tracking, prioritization, coordination, planning, execution and reporting. Define product quality, train personnel in new systems for inventory process tracking (CIM & SAP) and conduct corrective actions on customer complaints.

Master'S Degree, Master In Engineering Management

Bsie, Industrial Engineering