- Over twenty - five (25) years of experience supervising processing operations in the pharmaceutical / manufacturing industry.
- Well experienced in electronics Batch Records Authoring, Confidential Systems (PMX).
- Proven attributes in visionary and innovative thinking leading to practical applications in the delivery of products and services.
- Strong background in Deviation Reports Investigations, Training Developer, Auditing, Validations, Certifications, Quality Assurance, Sanitization Techniques, Solid / Parental Manufacturing and Electronic Batch Record Design.
- Increased Service Level from 96.5% to 99.1%
- Saved in cost by over $700,000 in materials usage per year.
- Established procedures to minimize defects that improved Quality Index from 95% to 98%.
- Established a reduced sampling plan resulting in a reduction of approval lead-time: three days reduction.
- Participated in ISO 9002 certification process as part of the production team assigned to revise procedures, conduct audits, and represent organization during certification audits; successful certification was obtained.
- Honored as recipient of the Excellence Award, while acting as director for Packaging Department Safety Program.
- Directed the implementation of High Performance Team that increase efficiency (55% to 88%), effectiveness (93% to 98%) and personnel motivation (absenteeism rate from 3% to 1%)
- Reduced documentation errors by 50% due to Batch Record Simplification Project implementation.
- MES Carolina Team ( Confidential ) recognized as the most efficient in the Corporate MES Implementation Initiative.
- 100 % manufacturing operators training completion through an entire year (3 times).
- Increase net yield by 1%. Represented to Formulation Department a cost saving over $800,000.
- Reduced Formulation Deviations related to job performance by 75% through an entire year.
- Increase by 25% the equipment sterilization capacity.
- Reduced Filling Department downtime related to sterilized equipment availability by 20%.
- Eliminate stoppers mixed up in the Fedegari stoppers washing and sterilization machine.
- Implement Seal Force Monitors. This exercise included FAT, SOP’s creation and training design.
- Sealing assessment to identify Media Fill failures and implement corrective actions to obtain three consecutive successful results.
- Increase 25% tablet production compressing capacity without personnel addition.
- Selected as Visual Aids Manufacturing Team Resource (FDA Response Team Site Certification).
- Team Member of MES Confidential Barceloneta, during the implementation of Corporate PMX & Global Project.
- Team Member of Pharma Suite Confidential System Implementation as recipe author and manufacturing support in Confidential Barceloneta during the system global implementation.
- Reduced Human Error Manufacturing Deviations by two consecutive years (2015-2017).
- MS Word
- MS Excel
- MS Power Point
- Manufacturing Deviations/CAPA’s
- Change Controls
Confidential, Caguas, PR
Compliance Specialist / Manufacturing Supervisor
- Annual Product Review Authoring
- Stability / Product Trend Data Analyst
- Supervise solid dose operations
- Deviations / Non-Conformances / Investigations
- Coordinates Third Shift Activities (staff: 25 operators & mechanics)
Confidential, Barceloneta, PR
MES Sr. Consultant
- Electronic Batch Record Recipes Author.
- Developing and execution of Validation Protocols, Amendments and Deviation Reports.
- Creation of SOP’s for Electronic Batch Record Disposition according Quality Compliance.
- Responsible of the Third Shift’s scheduling, training and production performance.
- Trained Manufacturing Second Shift Supervisor (Operational and Administrative tasks).
- Prepares manufacturing Monthly Schedule base on Logistic Department requirements.
Confidential, Carolina, PR
- Design and create Electronic Batch Record using Confidential Automation PMX MES.
- Responsible for the organization and coordination of the daily activities in the Equipment Preparation, Formulation and Sealing Departments in Aseptic / Non Aseptic Areas.
- Design sterilization loads and coordinates sterilization process validations.
Confidential, Vega Baja, PR
Manufacturing & Packaging Supervisor
- Responsible for all materials transaction from the Warehouse to the Floor stock (SAP).
- Supervises the processing operation including the chemical weigh, granulation, blending, capsule filling, compressing, coating and printing.
- Supervised and coordinated Ethical and O.T.C packaging lines (blisters & bottles) within the Pharmaceutical, Manufacturing Division (staff 64 operators and 5 mechanics).
Confidential, Manatí, PR
- Insured compliance with federal/state regulations (FDA, DEA, others).
- Supervised eight Operation Lines and Label Room (staff 50 operators/4 mechanics).
- Designated as Acting Plant Manager for second and third shift operations.
- Validated all documentation generated by Manufacturing / Quality Control Departments.
- Responsible for disposition of Raw Materials, Bulk Products, Packaging Components, Product Intermediates, Finished Products Water and Environmental Systems.
- Performed audits and training to insure FDA Regulations and Company Polices.
- Conducted complaints investigations identify cause and recommend corrective actions.