Medical Device Technical Writing. Investigations
Resume:
José Antonio Navarro Pérez
QA Consultant / Process Investigator
Personal Info
Phone
************@*****.*** 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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