José Antonio Navarro Pérez

QA Consultant / Process Investigator

Personal Info

Phone

787-***-****

E-mail

ad2m46@r.postjobfree.com Pharmaceutical and Medical Device Industry Professional with more than 20 years of solid experience with world class companies; Active Pharmaceutical Ingredient, Drug Products areas, Class II and III manufacturing areas, and Warehouse. Proven as highly responsible, analytical, a "right the first time" mindset and results oriented with strong leadership skills – Documentation Lead, Manufacturing GMP Coordinator, QE Inspector Supervisor, QA Manager, CAPA Lead, Sr. QA Specialist. Bilingual. Expertise in nonconformance / process deviation investigations, OOS, OOT, Warehouse/Inventory and Complaint Investigations. Domain in Investigative Techniques, Root Cause Evaluation Tools, Product/Patient Risk Evaluations, CAPA Implementations and Effectiveness Monitoring. SOP and Batch Design/Review and Change Controls. Process Monitoring by Statistical Process Controls (SPC). GMP Audits, Data Integrity, Trending Analysis and Metrics Reporting. My goal is to obtain a job in a company that allows me to show my abilities and knowledge. A job that let me prove my capacity to work under any circumstances and helps me improve my professional career and the prestige of the company I represent.

Experience

Languages

Spanish

English

Skills and Knowledge

Investigations / Complaints / CAPAs

GMP Regulated Environment / FDA

QA Systems / BR’s / Tech Writing

Maintenance and Facilities

Process Improvement / OpEx

Validations

Laboratory Operations

Oct 2020 -

Aug 2023

Jun 2019 -

Apr 2020

Nov 2018 -

Jun 2019

Oct 2017 -

Mar 2018

Feb 2017 -

Jun 2017

Independent QA /Compliance Contractor

Med Device and BioPharma Clients – Remote Projects (From home)

Provide remote QA consultant services to support QMS unit for Pharma, Med Device and BioPharma clients. Investigations, CCs, Audits, CAPAs, Training Support, Document Management (Veeva /Syncade). Serve as Senior Quality Supplier Manager responsible for the QMS of assigned Biological DS and DP External Suppliers (CMOs) within the Mammalian Cell Culture Production to include monoclonal antibody production, Microbial Fermentation, Drug Product filling, and Label & Packaging. Serve as primary interface between Quality and the Supply Chain Leads / 3rd Party Customers, and as the QA lead role in critical issue of quality supply chain issues.

Specialist, Compliance /Quality (Engineering / Facilities Areas)

Bristol Myers Squibb - Jones Lang LaSalle (Consultant) Manatí, PR.

Perform Engineering /Facility investigations including Pest Control sighting by leading Task Evaluations, Pest Monitor Data Analysis and CAPA proposals for implementation. Perform monthly audits to assure that program (Maintenance, Pest Control, Training) deliverables are met accordingly. Collaborate in the creation, modification and implementation of Procedures, Logbooks and Forms for the FE area. Track/Trend of all pest sighting incidents (GMP/Not GMP), and monitor results. Manage Data analysis for periodic Trending Report to Management. Responsible to create Service Requests (SR’s) to develop Job Plan for Preventive Maintenance (MAXIMO) activities. Provide training to FE team members to comply with regulatory and internal requirements.

Quality Compliance Investigator (Investigations / CAPAs)

Meridian Medical Technologies (Pfizer) (Consultant) St. Louis, MO.

Manufacturing Process, Warehouse and Internal Complaint Investigations. CAPA implementation and effectiveness monitoring, Perform Q1 Assessment for immediate response to reported manufacturing incidents or process related deviations. Provide Technical oversight and Support to other colleagues in Technical Writing and Investigational Techniques. Provide support in CAPA and Change Control Systems.

Sr. Quality Specialist (Remediation Project – Investigations / Complaints /CAPAs)

VistaPharm, Inc. (Consultant) Largo, FL.

Provide support in the creation and implementation of the Investigation, Complaints and CAPA System for the site. Technical oversight of process and warehouse related nonconformances and root cause CAPA reports including, to the extent required, performing risk assessments, address Data Integrity issues, reviewing root cause investigations and CAPAs, and authorizing closure of CAPA and CAPA effectiveness. Support on process improvement projects (ZenQMS System). Oversee data entered into quality systems for site non- conformances, CAPAs and complaints periodically to ensure compliance to local and global procedures. Compile and review quality indicator data periodically for trending purposes and present to management when required. Oversee site quality metrics related to quality indicators. Provide coaching on technical writing techniques and investigation tools to support the Investigation Team.

Investigator (Customer Complaints & Process Investigations/ CAPAs)

Baxter Healthcare (Consultant) Jayuya, PR.

Tools and Software

Microsoft Teams – Outlook/ Word/ Excel/ PowerPoint/ OneNote/ DocuSign

Investigation Tools – Ishikawa / 5Why's Trending / Pareto Charts

TrackWise / Veeva / Smartsheet

SAP / Process Pro / MFG Pro

Six Sigma / DMAIC / PDCA

CMMS - MAXIMO

Minitab - Process Monitoring

Environmental Monitoring Systems (EMS)

Interpersonal Attributes

Leadership Customer Service Public Speaking Coaching

Team Building Training Management Problem Solver Negotiation Skills Assertiveness Decision Making

Responsible and Accountable Reliable

Attention to Detail Thorough and Analytical Consistent

Time Management

Jun 2016 -

Feb 2017

May 2015 -

Jun 2016

Jan 2015 -

May 2015

Jul 2014 -

Dec 2014

Sep 2011 -

May 2014

Provide Support to the Product Complaint System by leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals to take appropriate actions in a timely manner. Conduct Investigations and establish Corrective Actions and FAR/Recall recommendation if necessary. Perform Initial Evaluations in order to determine Scope of the event, the Potential Impact to Process, Severity, Detectability and determine if the event constitutes a Systematic Issue. Perform Process, Data Integrity, Equipment and Facilities Nonconformance Investigations. Coordinate Efforts and event discussions with the Global Compliance Support and Customer Relations Teams. Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement. Ensures on-time completion of Complaints and NC Reports.

Quality Specialist (Nonconformance/Complaint Investigations)

Abbott Vascular (Consultant) Barceloneta, PR.

Perform Medical Device Nonconformance Investigations of Complaints and Manufacturing Process Deviations. Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events. Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement. Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to events. Perform Risk Assessment Evaluations. Provide training and system awareness on a site level. Develop, implement, and maintain procedures and work instructions (Change Controls). Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement. Ensures on-time completion of NCs and CAPAs. Review/ Approve W/O in Maximo System.

Technical Service Specialist (Manufacturing Investigations / CAPAs)

Pfizer Pharmaceuticals (Consultant) Barceloneta, PR.

Manufacturing Process and Internal Complaint Investigations. Corrective / Preventive Actions implementation and effectiveness monitoring. Validation and Cleaning Project Support. Process investigations of nonconforming events. Execute and provide support SOP and Master Manufacturing Instructions (MMI) revision, changes, training and implementation. Responsible for production area CAPA monitoring program and ensure timely completion of remedial actions, and measure effectiveness of such actions. Investigations associated to foreign material, yield discrepancies, printing OOS, equipment failure, pest control, environmental monitoring deviation, human error and “in process” test results OOS – OOP.

Project Support (Decommissioning / Documentation Evaluation)

Merck Sharp and Dohme (Consultant) Arecibo, PR.

Perform evaluation and removal for destruction activities of all documentation associated to the MSD material lifecycle (purchasing, testing, manufacturing, distribution, R&D, Quality, etc.) applying the client’s document retention policies and procedures. Documentation segregation, classification, filing, movement and storage/destruction of such documentation according to established instructions.

Process Investigator (Product/ Process/ Equipment)

IPR Pharmaceuticals (Consultant) Canovanas, PR.

Conduct in-depth investigation of product related failures events. Generates well balance reports of the investigation process, assuring accuracy and integrity of the data. Investigate internal and external complaints and perform evaluation / approval of level II and level III deviation reports. Support SOP and MPDs revision, training and implementation activities when necessary. Provide training in the investigation techniques as required. CAPA Effectiveness monitoring.

Quality Assurance Manager

Xerox Solutions of PR. Guaynabo, PR.

Responsible of managing the operation of the organization's Total Quality Management (TQM) Program. Oversee the development of systematic approaches for assuring high quality services that meet customer needs. Develops training and related reward systems. Develops, implements, and leads key process improvement efforts and influences cross-functional efforts. Develops systematic approaches for assuring high quality services. Project Management and Lean applications to increase quality results across the site and guarantee compliance with client’s Service Levels expectations.

Aug 2008 -

Sep 2011

May 2003 -

Aug 2008

Apr 2002 -

May 2003

Quality Engineering Technician / Manufacturing Ops Support

St. Jude Medical, LLC. Arecibo, PR.

Provide technical support to quality engineers by monitoring and identifying equipment and product non conformances, OOS Investigations and execution of packaging equipment related validations. “In process” statistical product inspection (SPC) and Process Monitoring. Root Cause Analysis and monitoring CAPA effectiveness. Development of processing tools that addresses non conformances root causes derived from investigations. Customer Complaints Investigations and involvement in the development of any process/tools (Six Sigma, SPC, Process Control Charts, etc.) changes to improve overall manufacturing processes and quality compliance. Assist in the preparation of trend and defects reports and monthly summaries.

Documentation Leader & Manufacturing GMP Coordinator

Procter & Gamble Pharmaceuticals. Manatí, PR.

Design, verify and audit Production Batch Records, Cleaning Records, SOP’s, maintenance records and "In Process” audits of all related documentation. Responsible for GMP compliance audits and CAPA follow ups related to the audit’s observations. Coordinate and monitor all PM / Validation / Change Control / OOT Test documentation for GMP compliance. Owner of the documentation sub team in the Human Error Elimination Team. Responsible for tracking/ analyzing documentation errors trends, and create action plans to meet expected results. Responsible for generating variance reports and lead investigations to the “root cause” in order to avoid recurrence.

Q.A. Incoming Inspector

Shering Plough, LLC. Manatí, PR.

Performed sampling and inspections for release on manufacturing components and exipients and also on packaging process materials. Performed tests, reports and provide final disposition approvals to be use in the manufacturing process. Conduct VIR’s (Variance Investigation Reports) in any discrepancy event, manage investigations and designate component status. (Quarantine, Hold, Conditional Release, Passed or Rejected). Conduct SCAR (Supplier) Investigations and request Vendor parts/product specifications for potential process improvement changes and validations.

Education

May 1993 -

May 1996

Universidad Politécnica de PR

•Mechanical Engineering - (Credits conducting to Bachelor Degree)

Aug 1990 -

May 1993

Colegio Nuestra Señora del Carmen

•High School Degree

Certificates

Jun 2005 Documentation Batch Record Review & Event Investigations Sep 2004 Human Error Prevention

Apr 2012 Lean Six Sigma Methodology and Tools Application for Manufacturing Process Improvement

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