RICHARD E. ORTIZ
Guaynabo
Summary
Professional with vast experience in the pharmaceutical industry and electronics industry. Oversee the integration of new products, quality assurance, and manufacturing. Process Owner Inspection & Packaging Lines Improvements (Vials & Syringes).
Skilled Production Worker offering more than 20 years of experience in pharma and medical device manufacturing environments. Focused on being productive and safety-minded at all times. Committed with strong production background. Focused on maintaining team safety and meeting challenging performance targets. Skilled in managing supplies and keeping line moving smoothly. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
11
11
years of professional experience
Work History
Engineering Contingent - Fab Sensor Non-GAAP
Medtronic
07.2022 - 11.2023
- Diabetic Equipment Validations and CSV such as Mask Aligner, EPL, Adhesive Promoter and others.
- Laser Marking Validation for Equipment Membranes.
- Fixture and Tooling Validation.
- Review and approve validations documentation.
- Increased customer satisfaction with timely and effective resolution of issues, providing personalized support to clients.
- Verified proper setup of project code and maintained on ongoing basis.
- Met production deadlines and managed time independently and with discipline.
- Enhanced team productivity by streamlining project management processes and implementing efficient communication strategies.
Sr Commissioning and Qualification Consultant
Janssen Pharmaceuticals
06.2021 - 04.2022
- Design and execution of Commissioning and Qualification protocols such as IQ, OQ, PQ, and CSV protocols
- Including Janssen access controls, security systems, and Controlled Substance Area Mapping
- Develop Commissioning Documentation and/or Protocols
- Manage multiple tasks, be able to work independently, and have strong oral and written communication skills
- Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
- Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
- Enhanced communication among team members to foster collaborative and supportive work environment.
- Identified areas of improvement for clients'' operations, implementing targeted solutions to increase productivity.
- Established best practices for project management within client organizations, leading to more predictable and successful outcomes.
Quality Scientist
Avara Pharmaceutical Services
07.2020 - 03.2021
- QA approval of process validation protocols and reports for manufacturing and engineering processes
- QA support for manufacturing activities, including Coating, Blending, and Compression
- Review Risk Assessment and FMEA documents review and QA approval
- Assign, review, and approve Change Requests including closeout
- Participate in the Internal Audit Process for automation, laboratory, and others
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
Process Owner – Packaging Area
Amgen
01.2017 - 06.2020
- Controlled line documents such as SOPs, Forms, Drawings, Reports, etc
- Recommend and implement Line Improvements
- Developed strong cross-functional relationships to ensure seamless communication among departments.
- Reduced production downtime through proactive maintenance scheduling and resource allocation.
- Conducted detailed root-cause analyses to identify areas for process improvement and implement corrective actions.
- Enhanced overall product quality by enforcing rigorous quality control procedures.
- Reviewed existing protocols for compliance with industry standards and regulations, taking necessary steps to address any gaps identified.
- Championed adoption of new tools or methodologies within the organization; provided training as needed to ensure successful implementation.
- Implemented business strategies, increasing revenue, and effectively targeting new markets.
Sr. QA Validation Specialist
Actavis Pharmaceuticals
10.2012 - 11.2016
- Document QA approvals for Commissioning and Decommissioning
- Reviewed and approved for QA Validation of Protocols, Validation Change Controls, Amendments & Addendums for validation equipment and facilities
- Responsible for commissioning and qualification, IQ/OQ/PQ for Packaging equipment
- Worked within packaging line validations
- Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
- Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
- Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
- Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
- Participated in external audits conducted by regulatory authorities demonstrating a high level of expertise and preparedness during inspections.
- Reviewed vendor-provided documentation critically assessing their capabilities in meeting project expectations before engaging in collaborations or outsourcing activities.
- Performed gap analyses between existing practices and required standards leading to the development of targeted action plans for compliance achievement.
Education
Associate of Applied Science - Electronics Engineering & Computers
University of Puerto Rico Mayaguez
Mayagüez, PRBachelor of Science - Biology
University of Puerto Rico Mayaguez
Mayagüez, PRSkills
- QA Internal Audits
- QA Supplier Audits
- Commissioning / Qualification
- Equipment
- Validation Protocols
- Consent Decree
- Technical Writing
- Metrics Reports
- Area Mapping
- Quality Systems
- Risk Management (pFMEA)
- CAPA’s
- Batch Records
- Investigations
- Change Control
- QA Validation
- Training
- Trackwise
- MS Office (Word, Power Point, Excel)
- Cross-functional coordination
- Sales experience
- Teamwork and Communication
- Attention to Detail
- Multitasking
Accomplishments
- Program Manager to save a pharmaceutical product that cost $7 million. Collaborated with team of new products in the development of Amgen project.
- Achieved company goals by 95% completing Statistical Process Control with accuracy and efficiency for production lines.
- Supervised team of 35 staff members.
- Documented and resolved consent decree issues for FDA which led to 100% efficient for Batch Records.
- Reviewed and approved (QA Approval) documentation for validation of protocols, validation change controls, amendments & addendums for validation equipment and facilities (QA validation).
Affiliations
American Society for Quality (PR Chapter), #00948041
Specializedtraining
- CSV (Computer System Validation)
- Six Sigma Green Belt Training, ASQ
- ISO 9001:2001
- Effective Documentation for Pharmaceuticals
- Aseptic Techniques
- New 21 CFR 210 & 211
- Quality for Business Success 2003
- Training Resources 2003
- Training Services for Industry 2006
- Quality Improvement Trainers 2008
- EPedigree & Serialization
Personal Information
Hobbies: Professional Wedding & Events Photographer / Instructor, Basketball Referee (Puerto Rican Basketball Leagues)
Timeline
Engineering Contingent - Fab Sensor Non-GAAP
Medtronic
07.2022 - 11.2023
Sr Commissioning and Qualification Consultant
Janssen Pharmaceuticals
06.2021 - 04.2022
Quality Scientist
Avara Pharmaceutical Services
07.2020 - 03.2021
Process Owner – Packaging Area
Amgen
01.2017 - 06.2020
Sr. QA Validation Specialist
Actavis Pharmaceuticals
10.2012 - 11.2016
Associate of Applied Science - Electronics Engineering & Computers
University of Puerto Rico Mayaguez
Bachelor of Science - Biology
University of Puerto Rico Mayaguez
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