Sales Injection Molding

LINNETTE I. SANCHEZ RODRIGUEZ

Accomplished professional with eighteen (18) years of experience within the Pharmaceutical, Medical Devices and Technical Sales. Experienced professional in areas such as: Validations, Quality, Regulatory Compliance, and Process Engineering. Skilled professional on assessing the Validated State of computerized/non-computerized systems Experienced in technical writing/executing and closing IQ/OQ/PPQ protocols for fully –automated processes. EXPERIENCE

THE FOUNTAIN GROUP, INC.

Periodic Validation Review (PVR) Consultant – Alcon, Johns Creek, GA March/2016 to December/2016 Responsible of writing, executing and closing Periodic Validation Reviews for computerized/non-computerized equipment in areas such as: Analytical/Microbiology Labs, Utilities, Optical Tooling, Peel Testers, Cleaning, Data Acquisition Systems and Spreadsheets.

Highly experienced with assessments on the validated state of computerized/non-computerized systems through verifications including: Validation Life Cycle documents, Operational Procedures, Equipment Logbook, Audit Trails, CAPA, Change Control, Non-Conformances, Software Versions.

Highly experienced with evaluations of Validation Life Cycle documents such as: Validation Plans (VP) Users Requirements Specifications (URS), Functional Design Specifications (FDS), Traceability Matrix (TMx), Assessments (i.e. Quality Needs (QNA), Impact (IA) and 21 CFR Part 11 Assessments), Spreadsheet Validations, Commissioning, Decommissioning, DQ/IQ/OQ/PQ, Validation Closing Reports.

Contributed and supported client’s Compliance Strategy.

Successfully achieved client’s aggressive project due dates by involving key supporting areas such as: Subject Matter Experts (SMEs), Facilities/Utilities, Controls Engineering, Quality, System Owner, Validations and E- Compliance.

ISPV INC. February/2015 to May/2015

Senior Validation Consultant – Nesher Pharmaceuticals St. Louis, MO Responsible of writing, executing and closing IQ/OQ protocols for laboratory/R&D equipment and utilities for a remediation project under a consent decree.

IOQ protocol of a vacuum system utility supporting laboratory fume hoods.

Closing IOQ protocols for R&D laboratory equipment.

Developing final summary reports and deviations for IOQ lab fume hoods.

Support of Cleaning SOP strategy.

ADVANCED SS, ENGINEERS AND CONTRACTORS October/2014 to February/2015 Senior Validation Consultant – Cooper Vision Caribbean Corporation (CVCC) Juana Díaz, PR Responsible of providing validation support in writing, executing and closing IQ/OQ/CSV/PPQ protocols. Validations support consisted as follows:

IQ/OQ/CSV/PPQ protocols of a new fully- automated demoulding, hydration and sealing/labeling/packaging machines for Toric contact lenses. Process equipment validated included: PLC/HMI integration, Automated Vision/Inspection and SCADA.

CSV protocol tests were covered under IOQ protocols for this project. QUALITY CONSULTING GROUP, INC. March/2014 to October/2014 Senior Quality Engineer – Zimmer Manufacturing Ponce, PR Responsible of auditing / approving qualification protocols for hip replacement orthopedic medical devices to assure regulatory compliance requirements as part of a remediation project for the Food and Drug Administration (FDA). Quality Engineering support consisted as follows:

Regulatory/QE support on documentation assessments within laboratory areas and orthopedic implant processes.

Regulatory/QE support for Validation Plans strategy and IQ/OQ/PQ protocols for orthopedic implants processes.

Regulatory/QE support for Test Method Validations/Gage R&R for Coordinate Measuring Machines. Mobile: 787-***-****

E-mail: ********.*******@*****.***

Home: 4081 Lost Mill Ln

Buford, GA 30519

EXPERIENCE

(cont.) ADVANCED SS, ENGINEERS AND CONTRACTORS March/2013 to February/2014 Senior Validation Consultant – Cooper Vision Caribbean Corporation (CVCC) Responsible of providing validation support in writing, executing and closing IQ/OQ/CSV/PPQ protocols. Validations support consisted as follows:

IQ/OQ/CSV/PPQ protocols of a new fully- automated demoulding, hydration and sealing/labeling/packaging machines for several contact lens models (i.e. Toric, Sphere, Biomedic).

IQ/OQ protocols of CVCC Soft Water Distribution System including new equipment such as a soft water storage tank, water softener and a fully-automated integration of the Soft Water Distribution System.

IQ/OQ protocol of an Ethanol Storage Tank used in the manufacturing process of silicone contact lenses.

IQ/OQ protocols of new electrical Injection Molding Machines for contact lenses molds, which include: Injection Molding Machines with its integrated robots, filling/close robots and monomer curing ovens.

CSV protocol tests were covered under IOQ protocols for these projects. WARREN DEL CARIBE, INC. October/2011 to December /2012 Account Manager- Manufacturing Segment

Responsible of electrical, automation sales within the Southwest territory.

Managed established accounts and develop new potential accounts.

Developed $3.5 Million in opportunities within new markets such as data communications and power distribution.

Increased territory sales in 29% compared to last year results.

Increased territory gross profit in 25% compared to last year results.

Achieved 25% gross margin versus 22% gross margin goal. RICOH-PR October/2009 to October/2011

SMB Commercial Sales Consultant

Responsible of printing and digital solutions’ sales within the Southern territory including some strategic major accounts.

Managed established accounts and developed new potential accounts for equipment sales.

Executed proposal’s documentation for integration projects.

During the first year with the Company, accomplished thirty-eight (38%) increase in sales revenue.

During the second year, successfully closed $275,000 in sales on strategic accounts assigned as a special project.

Accomplished 121% of sales goal on August/2011, obtaining ranking position #2 in YTD sales goals among sixteen (16) Commercial sales reps. Ranked within the top five (5) Sales Consultants in 2011 out of thirty-six (36) sales consultants in RICOH – PR.

Recognized as Sales Consultant of the Month from August to September/2011. MULTISYSTEMS, INC HATO REY, PR June/2008 to Sept/2009 Account Manager – Puerto Rico

Responsible of equipment sales for barcode solutions within the manufacturing market in PR territory.

Acquired products experience in bar code solutions’ equipment such as: automatic printers and label applicators, laser marking, inkjet printing systems, bar code scanners, RFID and integration projects requiring equipment and custom software development.

Managed established accounts and developed new potential accounts for equipment sales.

Executed proposal’s documentation for integration projects.

During the first year with the Company, accomplished thirty-two percent (32%) increase in sales revenue. SYNOVIS CARIBE, INC., DORADO, PR Feb/2005 to Aug/2006 Sales Representative – Puerto Rico

Responsible of developing new accounts within medical devices markets in PR such as cardiac rhythm management, interventional vascular, neurological and surgical for this new Company established in 2003.

Developed strong relationships with potential new customers.

Obtained approval as supplier from two of the top five medical devices customers in PR.

Developed strong relationships with Engineering, Sales, Manufacturing and other departments with Synovis headquarters in Lino Lakes, Minnesota.

Responsible of coordinating Company’s participation in trade shows such as: PR Interphex 2006, NYC Interphex 2006 and PR Manufacturers Association.

EXPERIENCE

(cont.) GE ADVANCED MATERIALS, PLASTICS June/2002 to Jan/2005 Account Manager – Puerto Rico

Responsible of thirty (30) PR accounts sales/revenue within markets such as Telecommunications, Electronics/Electrical, and Medical Devices.

Acquired plastics products experience.

Developed excellent relationships with Customers.

Successfully coordinated the PR Medical Molding Seminar in PR offered by GEAM.

Accomplished nineteen percent (19%) increase in sales revenue year over year.

Developed strong relationships with Customer Service, Marketing and Technical Services to support PR territory. OCULAR SCIENCES, JUANA DIAZ, PR

Quality Operations Manager Jan/2001 to May/2002

Responsible for the QA Operations which included Incoming Inspection, Microbiology and Chemistry Labs, QA in-process and Final Product Release functions which comprised six (6) QA Supervisors. One Lab Manager and over 100 QA and Lab technicians.

Achieved budget plan in terms of QA Product Release requirements.

Dramatically reduced inventories within QA Quarantine Cages by fifty-nine percent (59%).

Contributed to the implementation of a Quality Culture program.

Implemented internal Document Control within QA areas.

Achieved incoming inspection procedures enhancements. OCULAR SCIENCES, JUANA DIAZ, PR

Compliance Assurer Nov/1999 to Jan/2001

Support to international marketing requirements.

Successfully contributed to the implementation of Engineering Change Management System.

Developed and deployed the Quality System Regulation (QSR) training for OSPRI employees.

Exposed to Material Review Boards.

Completion of CAPA investigation reports in a timely manner.

Support Pre-Market Approval submission for new OSPRI Juana Díaz facilities.

Successfully supported Master Validation Plan strategy for new OSPRI facilities/equipment.

Contributed to FDA post approval inspection which resulted in no 483 observations. OCULAR SCIENCES, JUANA DIAZ, PR

Manufacturing Engineer Jan/1999 to Nov/1999

Responsible for executing process improvements/cost reduction for manufacturing areas.

Revised SOP’s plant wide.

Successfully designed, improved and implemented ergonomic stations.

Dramatically reduced new facilities expansion costs ($1 Million) by completing new clean room layout for Juana Díaz new facilities.

Successfully increased by 24% manufacturing line capacity. BAXTER CARDIOVASCULAR GROUP, AÑASCO, PR

Manufacturing Engineer 1997 – 1998

Responsible for executing process improvements/cost reduction and validation projects for manufacturing cells. Directed minimization of production scrap, ergonomic station design and implementation of Total Preventive Maintenance. Fully responsible for market complaints corrective actions and provided support to environmental waste reduction programs. Met compliance with OSHA and GMP regulatory issues.

Dramatically reduced scrap up to $522,000.

Successfully completed and implemented on-time plant wide projects without negative impact on plant operations.

Implemented on-time component changes, obtaining savings of $155,000.

Met audit corrective actions within timetables.

EXPERIENCE

(cont.)

BAXTER CARDIOVASCULAR GROUP, AÑASCO, PR

Engineer/Production Supervisor (first & second shift) 1996 - 1997 Responsible for the coordination of production scheduling in a continuous flow environment, reduction of manufacturing cycle time and compliance with inventory management strategy. Full responsibility for reducing production scrap, increasing line and labor efficiencies and designing of ergonomic stations. Met compliance with OSHA and GMP regulatory issues.

Reduced top three defects by 37%.

Increased yield from 95% to 98% in high-volume products.

Achieved build plan with zero backorders.

Exceeded production efficiency goals.

Achieved floor stock accuracy by 50%.

Successfully increased manufacturing line flexibility to improve capacity.

Achieved zero observations on internal and corporate audits.

Participated as sponsor for Employees Suggestions Committee. BAXTER CARDIOVASCULAR GROUP, AÑASCO, PR

Industrial Engineer 1995 - 1996

Responsible for the improvement of warehouse material flow and space utilization. Special projects: Warehouse labor standards, warehouse consolidation and layout design, material movement analysis, and improvements of incoming inspection operations.

Successfully completed warehouse consolidation project and layout design.

Improved warehouse material flow and space utilization.

Improved incoming inspection workflow.

EDUCATION

UNIVERSITY OF PUERTO RICO,MAYAGÜEZ, PR 1995

BS in Industrial Engineering

SEMINARS Supplier Quality Assurance • Supplier Performance Measurement • Labor Law • Introduction to SPC and Capability Studies • Introduction to Six Sigma Quality • Acceptance Sampling • Product Reliability and Prediction Measurement • Material Requirements Planning • Total Quality Management • Problem Analysis • Regulatory Requirements • Principles & Practices of Regulatory Affairs • QSR • Design Control/Validation Academy • Fifth Annual Regulated Industry Conference “Recognizing Compliance as a Building Stone within the Organization” • Fundamentals of Injection Molding Basic Selling Techniques Strategic Account Management Plann ing Basic Negotiation Skills Selling During Rough Times Datalogic Unattended Scanning Systems RFID Zebra printer solutions Symbol scanners for 1D/2D barcodes Inkjet printing solutions Laser marking Leadership Academy Digital Solutions/Equipment Knowledge Based Basic PLC Essential Components Power Control/ Distribution Equipment Lighting Basics Sensors Training

SKILLS Fully Bilingual in English and Spanish. Proficient in software use and applications such asMicrosoft (Word, Excel, PowerPoint, Outlook), Sales Logix, ACT, Sales Force, Agile, TrackWise.

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