Experience

Business Excellence Consulting, Inc. (PR and Spain Divisions)

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Quality Assurance Expert

  • Aug 2021 - Present

  Execution of Independent Third Party Batch Records Review and oversight on activities related to each manuafacturing batch such as investigations, qualification and validation activities, etc. Evaluate data received for completion and approval recommendation of batch product release thru performing assessment as established in the Batch Record Review Checklist. Also participate in the Walkthrough workstream activities all this as part of the Remediation Project Plan for KVK Tech located in Pennsylvania, USA in agreement with FDA stipulations. Show less



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality System Specialist / Training - Contract

  • Aug 2016 - Sep 2019

  Administer the Learning Management System (LMS) related to all training plans, courses and certifications for quality system and manufacturing procedures and related documents such as drawings, layouts, work instructions, etc. Maintain accurate training records in system by performing course and certification creation and corresponding versioning, entry of course sessions and participant attendance sheets. Provide training reports as required/needed. Assist in the preparation of on-the-job training certifications and proper assessment tools. Lead the training effectiveness methods review initiative at the site to ensure alignment of tests with related operational procedures. Manage the Change Control System to review and approve documents for implementation as per change control process in place. Assist the manufacturing business units on training system and documentation matters Show less



McNeil Consumer Healthcare

• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Aug 2011 - Jun 2015

  Performs the final QA approval to raw materials, bulk product for subcontractors, packaging components and finished products through the electronic control system. Generate, review and complete non-compliance reports and QA investigations. Ensure that the quality systems are in accordance to the Good Manufacturing Practices, as established in the Code of Federal Regulations and procedures. Serve as liaison between McNeil Operations group and the cGMP Expert at the site for Batch Record Review purposes as per existing Consent Decree agreement and stipulations. Show less

• • 2011 - 2014

• • 2011 - 2014



Zimmer Biomet

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sr. Quality Supervisor

  • Aug 2004 - Feb 2011

  Zimmer is a Medical Device Manufacturer of joint replacement implants with over 600 employees in PR and worldwide sales over $7B. Perform as In-Process Quality Supervisor for daily operations inspection activities. Administer the Document Control system by coordinating all aspects of the development, control, review, revision, distribution and publishing of ZMBV procedures. Supervise the day-to-day operation of the Change Management System (CMS) for procedures, forms, blueprints, including revision and corresponding approvals. Develop, modify, and implement compliance metrics. Coordinator for the preparation and execution of the site’s Quality System Management Review sessions. Supervise seven (7) non-exempt staff personnel. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• • 1990 - 1991

• • 1990 - 1991