Paseo De Reyes
Calle Rey Fernando #E-69
Juana Díaz, Puerto Rico 00795
QUALITY / MANUFACTURING / PLANNING
Goal-focused professional with more than fifteen years of experience. Recognized for professionalism, trust-worthy, resourcefulness, and competence in supporting organizational goals. Adept in handling confidential matters. Proven tact, persuasiveness, analytical, high work ethic, attention to detail and consistent ability to make things happen in a fast-paced environment. Expertise in, problem identification, training development, resolution, relationship and team building. Strong business writing & verbal communications skills.
Work well under pressure and minimum supervision.
Efficient, highly analytical and capable of making tough decisions.
Proactive mindset and strong leadership qualities.
Fully bilingual, Spanish and English.
Baxter Healthcare Corp, Jayuya PR (2018 – 2019)
Production Supervisor – (2018 – 2019)
Coordinate daily manufacturing activities related to the formulation of IV bags, cleaning and sanitation of all control rooms including, change room, weighing room, mixing rooms, formulation tanks and filling lines.
Setting priorities to achieve maximum manufacturing efficiency by effective organization of direct reports.
Studies production schedules and estimates worker hour requirements for completion of job assignment.
Schedule material usage with other areas (Material Department, Warehouse)
Assist in trouble shoot and provide technical support to associates.
Enforce company policies (cGMPs, SOPs) to workers and enforce safety regulations.
Audit and approve all manufacturing records and assure they are in compliance with all specifications.
Experience in Packing Process including Cartoner Machine, Inserts, Carton weight Balance, Sealer and Palletizer.
BD Caribe LTD, Cayey, PR (2004 – 2018)
Planner / Buyer – (2016 – 2018)
Evaluates business plans and establishes production schedules for the Sensi Disc mfg area based on APO/R3 recommendations in support of financial plans. Takes into consideration departmental efficiency, stable manpower planning, customer service objectives and inventory goals (back order avoidance) in the established schedules.
Executes the production schedules through the issuance of work orders and monitors production department performance against schedules.
Expedites back order conditions and production priorities and coordinates the achievements of priorities with all-involved department and publishes reports on products status and availability information internal and external. Customer Service/Marketing on an accurate and timely basis.
Initiates actions to reduce excess and obsolete inventory and minimize stock loss through request for re-testing, extending shelf life and repackaging. EXPERIENCE:
• Workflow Planning
• Discipline Issues
• Lean Mfg
• Documentation & Reporting
• Strong Follow-Up
• Communications Skills
• Team Building
• Computer Skills (Word,
Excel, Power Point and
Outlook) & Internet tools.
• KT CAPA
• Train the Trainer
• Technical Writing
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Attends weekly manufacturing, planning conference calls and any schedules products specific meetings when applicable.
Coordinates with production personnel priorities and demands and keeps them informed have planned monthly deliveries, and reports in advance any deviation from planned or promised deliveries. Analyzes Backorder and expected stock loss reports to ensure backorders and product losses are minimized.
Analyzes MRP reports for its accuracy, completeness and required action.
Control and monitor inventory levels to assure an acceptable level to support the demand and budget.
Keeps constant and clear communications with the Materials leader relating to any delivery, quality or inventory problem, which may cause an impact in the business.
Conducts, reschedules, expedites and cancel purchase orders in the system as needed to maintain accurate performance reports.
Update in SAP past due Purchase Order dates in a timely manner as needed. Manufacturing Supervisor – 2004 - 2016
Coordinate daily manufacturing activities by prioritizing business needs such as: stocks products from Japan and Belgium or other special products.
Maintain Training Program (C2C) compliance at a minimum of 98% by monitoring weekly reports and assuring training curriculums up to date.
Provide support to on-going Lean Manufacturing activities and metrics.
Maintain employee’s records and attendance.
Recommend and execute personnel actions such as: evaluation and promotions.
Review batch records, antibiotic expiration and revised equipment used in formulation area.
Write or revised SOPs for existing processes and products.
Responsible for protection and maintenance of equipment and facilities under my work area in accordance with the company standards.
Constant communication with QA Facilitators for evaluation of product release issues and new product coordination.
Improve customer service through controlling backorders.
Coordinate validation activities when applicable, write protocols and execute activities.
Coordinate new product development activities: Prepare pilot lots, prepare master data product structure, follow up with QC for antibiotic release and product testing, follow up with master data for completion.
Determine standards, budgets, production goals and rates based on company policies, equipment, labor availability and workloads.
Support Dipping area by overviewing processes; deal with downtime equipment issues, cleaning system, etc.
Monitor quality notifications and complaints related to the area to evaluate if there is any trend on any given product.
Complete annual performance reviews for hourly and indirect associates.
With HR assistance resolved worker problems and complaints.
Observed work and monitor gauges, dials and other indicators to ensure that operators conform to production or processing standards.
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• PFIZER PHARMACEUTICAL, Caguas, PR 2002-2004
Monitor product quality to ensure compliance with standards and specifications.
Provide technical support and assistant to chemist and laboratory technicians.
Compile and interpret results of tests and analyses.
Perform data verification, analytical and lot disposition.
Assist in laboratory investigations.
Provide support to administrative tasks such as: planning, scheduling and personnel within the laboratory.
Laboratory Quality Reps team member which includes: giving support to indicators like RTFT, walk through and creating consciousness to assure quality and compliance with regulations and cGMPs. Laboratory Technician – 2000-2002
Analysis of finish product and samples stability.
Perform laboratory equipment calibration and verification such as: analytical balances, UV/Visible Spectrophotometer and dissolution bath.
Perform Assay, Content Uniformity and Dissolution test using HPLC method in the identification of actives components and impurities.
Prepare test solutions, compounds or reagents for laboratory personnel to conduct tests.
Maintain laboratory instruments to ensure proper working order and troubleshoot malfunction when needed.
Experience in HPLC, GC, UV/Visible, IR and Karl Fisher instruments.
Prepare technical reports, standards and specifications for processes, facilities, products or tests. EDUCATIONAL BACKGROUND
Pontifical Catholic University of Puerto Rico, Ponce, PR Bachelor Degree in Chemistry
ADDITIONAL INFORMATION AVAILABLE