Data Analyst Project Coordinator

Patricia Gomez

Mira Loma, CA *****

520-***-**** ; **********@******.***

Seeking full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Summary of Qualifications

Strong understanding of FDA guidelines and Regulations, ensuring that product gets released with all the necessary documentation and SAP transactions completed.

20 + years of Quality related positions including managerial & production supervisory roles.

Attended MRB to review NCR’s and helped with Investigations, working knowledge of SAP and Agile.

Manage initiatives to keep leaders informed and optimize worker training.

Detail-oriented team player with strong organizational skills.

Ability to handle multiple projects simultaneously with a high degree of accuracy.

Worked closely with Process and Equipment Development Team for Stent Manufacturing, Ballon Manufacturing and Delivery System and ensuring each process was integrated and completed with the required Validations.

Canary Medical Oceanside, CA 2022 – Current

Quality / Clinical / Manufacturing

Responsible and accountable to help all organizational team and function in succeeding in delivering design control specifications, technical transfer requirements, process optimization, complete product and process verification and validations

Executing to the proposed project plan by forward apprehension of technical factors and implementation of effective problem-solving methods

Quality and Regulatory Project Management in Class II & Class III medical environment

ROCHE/ Ventana Medical Systems, Inc 2007 – 2019

Clinical Sciences Project Coordinator

Coordinates assigned projects development and execution and maintaining project schedules and communication to stakeholders

Proactively responds to project schedule delays utilizing knowledge and judgment to determine the best corrective action to recommend to the project team and management

Facilitate the preparation and review of deliverables for clinical and lab services projects, and the logistics of a harmonized sample process flow (between CSM, BSM, Histology, and Pathology)

Interfaces with laboratory personnel, quality control and the medical and scientific staff; coordinates data reporting

Compiles and summarizes data and generates standard and ad hoc reports as needed

Makes appropriate recommendations to management to improve process efficiency

Tracks identified activities relating to clinical study management projects and facilitates communication between various functional groups throughout the organization as required to expedite clinical study execution and project deliverables

Quality Assurance Technician 2005 - 2014

Ensure that all Reagent Teams needs are being met consistently and ensuring that product gets to finished goods in a timely manner, here in Tucson, Hungary, and outsourced vendors

This is accomplished by aligning with the Planner, Team Lead and co-workers to ensure that we consistently meet the needs of our customers

Cross trained on all Reagent Teams products or processes

Attended MRB to review NCR’s and helped with Investigations

Working knowledge of SAP and Agile

MDMI Richmond, Canada 2002 - 2004

Manufacturing Manager

Medical device manufacturing Start-up Company located in Richmond, BC; Canada

We had multiple production lines for different types of products

These product lines consisted of a thermal control unit, and disposable catheter for a thermal endometrial ablation device, a PTCA Catheter product line and a contract manufacturing line

Initiated all the necessary documentation to transfer the product from R&D into Manufacturing

retrieve necessary testing requirements from lab notebooks and initiated the specifications for the endometrial ablation device with very minimal assistance from R&D Engineers

Worked with various international agencies including CSA, which is the equivalent of Underwriter's Laboratories.

Medtronic AneuRx Division 1995 - 2000

Sr. Manufacturing Supervisor

During my tenure in this Division, we had a recall and we had to re-structure our production area and re-validate our systems

Worked closely with QE / ME Engineering and revised 90% of our Manufacturing process instructions to ensure that we would be capable of passing an FDA audit

Managed to beat and exceed our production goals for 6 months straight, yields went up significantly and the NCMR’s were reduced by 75%

Guidant - Temecula

Supporting the organization IPO creating a business market value of 800 million dollars

Each platform was completed in a 9-month timeline, design to market cycle (MS11, GFX, GFX 2.5, GFX 2, S670, S660, OTW and RX delivery system

Worked on the Clinical Evaluation line for the Ostial Stent, SVG Stent and delivery system, the Bifurcation Stent, and Delivery System

Education

Business

Palomar College, Palomar, CA

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