Juan R. Massas

**** **** ** *** **** # *****

Clearwater Fl, 33759

787-***-****; ac0w8h@r.postjobfree.com

Key Accomplishments

Biotechnology Industry

• Implementation of new technology and methods to test syringes for compatibility with auto injector devices such as Strength, Glide Force and Silicone Distribution tests.

• Installation of vertical carrousel storage system for site reserve samples.

• Installation and Validation of Isolator for the sampling of Raw materials, Inert gases distribution systems, Laminar Flow Hoods, and Clean rooms environmental monitoring.

• Construction of IQA department classified sampling rooms and modification of lay out of IQA staff offices.

• Reduced to 50% the number of Non conformances generated for Manpower and Method causes.

• Reduced the amount of instruments assigned to IQA department from 208 to 119 based on assessments of use vs. inspection. Assess the calibration intervals of instruments to assign the correct ones. These initiatives reduced the cost of calibrations performed to non necessary instruments and the human hours assigned to perform these calibrations.

Medical Device Industry

• Implementation of SPC system for quality and manufacturing areas.

• Successfully validated Molding, Thermoforming, Packaging, Heat and RF sealing machinery.

• Designed experiments to improve operational efficiency of site machinery.

• Identified, investigated and implemented corrective actions for recurrent non conformances events and reduced to 40% the number of Non conformances generated.

• Successfully complies with EPA water discharge parameters after recruited due to EPA warning letter for waste water discharges out of limits.

• Design of sampling and inspection methods for QC operations that reduced the amount of time and manpower.

• Accountable for the ISO 9002 certification.

Experience

Amgen, Juncos, PR 2005 - Present

QA Specialist:

• Incoming and Warehouse areas Quality Specialist. Knowledge in Sampling and Inspection methods, SAP, EDM-Q (Documentum), efinity, Trackwise, CCMS (Change Control Management System), Maximo, Minitab and others systems related to QA department operations.

• IQA department calibration and classified rooms system owner. ARMS system alarms owner.

• NC/ CAPA/ Change Control Owner and Non regulatory assessor. NC/CAPA QA Contact.

• Generation of new SOP’s, Forms, Investigation Reports, Protocols and Interim Reports in EDM-Q system. Owner of clean Classified Rooms and supervise clean rooms Sanitors crew.

• Support Supplier Quality Management (SQM) department trough change control assessments, implementation of new sampling and inspection methods, and acquisition of new equipments to comply with specifications requirements and supplier related non conformance investigations.

• Accountable for preparing QA Metrics, inform to top management and follow up and support on metrics goal achievement. Bulk Drug Substances documents review, sampling and inspection.

• QA Project Owner. Knowledge in Material Quality, Specifications, Calibration of instruments and Validation of equipments.

• Implementation of new technology and methods to test syringes, vials and other components in order to comply with specifications testing’s and inspection criteria.

• QA department regulatory inspections liaison, presenter of department operations. Provide recommendations for findings corrective actions and close applicable CAPAs. Colgate - Palmolive, Juncos, PR 1998 – 2005

QA Specialist:

• Responsible for Incoming & final audits of finished goods. Design inspection base in AQL sampling methods.

• Responsible for the implementation and training of SPC programs in the Q.C. testing area. In charge of monthly CPK reports. Analysis of data & real time process control graphics.

• Generate new SOP’s & Work instructions for the Quality System. Perform qualifications training for new Q.C. Inspectors. Generate documentation and analysis for Non-Conforming products, Deviations, Corrective & Preventive Action Requests (CAPA), and Technical & Investigation Reports

& Change Control.

• Administrate plant Calibration system and validation of molding and packaging machinery.

• Administrate Supplier Quality Management (SQM) system; perform Supplier qualifications and audits to suppliers.

Colgate - Palmolive, Juncos, PR 1990 – 1998

Environmental Technician & W.W.T.P.O.

• Responsible for the operation & analysis of the W.W.T.P. equipment, the management of Hazardous wastes & compliance of federal regulations. Fill manifests & Monthly reports.

• Corporate Environmental Auditor with knowledge in regulations like: EPA, SARA, RCRA, SPCC, BMP, GMP & others.

A.M.I. Gibson Inc., Luquillo, PR 1989 – 1990

Waste Water Treatment Plant Operator & Q.C. Inspector

• Engineered the operation of two chemical process W.W.T.P. & Hazardous Wastes management.

• Perform inspections and approvals of raw materials, metallic dusts and finished Contacts. Education

Bachelor in Sciences, Biology.

Minor in Microbiology.

Interamerican University of PR Cupey, PR

Seminars and Professional Developments

• Change Control Management System

• Fundamentals of auditing

• Investigation Skills Work shop

• Standardized Root Cause Analysis Foundational Skills

• Investigations Causal Factor Analysis

• Quality Management Tracking System (QMTS)

• Glass Forensic Analysis

• ISO 9000: 2000 Certified Auditor

• Practical Control Charting (SPC)

• Fundamentals of Effective Writing Skills

• Technical Writing

• Advance Hazardous Waste Management & Applicable Regulations of EPA

• Waste Water Treatment plants operation

• Applicable Regulations of EPA & DOT

• Environmental Auditor Training

• Health & Safety for hazardous waste operation & Emergency response Skills

Languages: Fluent speaking, reading & writing English & Spanish. Computer Literate: MS office, Minitab, EDM-Q, SAP, SPC IV, JD Edwards, Track Wise, Maximo, Change Control Management Systems (CCMS) & others. SPC Trainer, Self-starter & team player. Experience in equipments maintenances and calibrations. Design Validations, Experiment, Analytical methods & Inspections.

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