Quality Assurance Data Entry

A pharmaceuticals and medical device professional with 20+ years of experience in the San Diego area where I have been able to grow in our industry to gain the experience and knowledge of FDA Regulations; 21 CFR Part 11, Part 210, Part 211 and Part 820, and with ISO 13485 along with my project management, communication and organizational skills in Quality Assurance.

EXPERIENCE:

Sep., 2024 – Carlton National College Station, TX

Present Quality Compliance Contractor

Working with the Quality and Manufacturing team to review current processes for gaps to make recommendations.

Recommendation in CAPA initiation, review and approval in TrackWise.

Review procedures to make recommendations in company’s FDA response.

Responsible to ensure the company’s policies and site procedures follow regulatory agencies requirements.

Aug., 2021 – Tanvex BioPharma USA, Inc. San Diego, CA

Jan., 2024 Quality Assurance Compliance Associate Specialist

Manage the Supplier Qualification Program and maintain the Approved Supplier List. Work with a consultant to perform vendor audits. Perform internal audits to ensure compliance with applicable regulations.

Manage and lead the backroom during Mock Audits and Agency Audits.

Manage the Vendor Change Notification process by being the point of contact to receive all vendor change notices. Coordinate review of notices by SME and stakeholders. Track action items resulting from the vendor change notification. Follow-up communications with vendor for documentation. Facilitate meetings as necessary.

Schedule, track, perform supplier onsite, virtual, and desktop audits of company’s suppliers. To include preparing the audit agenda, relay observations with follow up of complete, author Final Audit Report

Prepare and maintain the Inspection Readiness System, perform, and ensure company employees are trained in GMP operations and in preparation for Inspections.

Perform On-Boarding GMP and MasterControl training for new employees.

Assist with procedural gaps and creating or revising procedures related to compliance with applicable regulations.

July, 2018 – Thermo Fisher Scientific Carlsbad, CA

Dec., 2020 IT QMS Compliance

As a member of the IT QMS Compliance Team, responsible for new implementations and upgrades of MasterControl for multiple business units, world-wide within Thermo Fisher Scientific

Serve the end-user business community and the governing corporate quality team to ensure software solutions are well understood and built for intended use.

Following Software Development Life Cycle, coordinate and manage validation documentation, execution and approvals.

Nov., 2016 – Fitbit, Inc. San Diego, CA

July, 2018 Sr. Quality Management Systems Engineer

Responsible for leading the QMS team in establishing, implementing and maintaining systems to measure and improve product quality, customer service while ensuring full compliance to applicable regulations.

Leading, establishing and monitoring systems related to Inspection, Training, Supplier Qualification, Manufacturing, Complaints, and Corrective/Preventive Action.

Led the Quality Team/Company to two successful ISO Audits and Annual Internal Audit with no Findings

Have increased the Complaint Closure / Approval rate by 400% over a four-month period while sustaining a 500% increase in Complaints Reported. Report Weekly Complaint & Training Metrics to Quality Management. Review complaints to determine if a MDR is required.

Lead Weekly CAPA Review Board Meetings to ensure the timely investigation / status of open CAPA’s

Manage Company-wide QMS Training Program

June, 2014 – Sotera Wireless, Inc. (Medical Device) San Diego, CA

Oct., 2016 Manager, Quality Systems

Quality Approver for release of medical device to hospitals for patient care.

Audit team lead and scribe of successful ISO Audits, CA State Audits and FDA Audits

Manage the Product Complaint program for 40+ sites while decreasing the number of days between Complaint Notification & Complaint Approval by 30%

Manage the Document Control, Calibration, Training, Complaint & CAPA Programs, work with internal and external personnel. Report

Weekly Metrics to include Incoming Inspection & Product Release Metrics to Executive Management.

Work with Software Engineers for implementation of Complaints & CAPA workflows in JIRA

Mar., 2013 – Pacira Pharmaceuticals, Inc. San Diego, CA

April, 2014 Senior Quality Assurance Associate

Project Manager of a department stakeholders for MasterControl system selection

As company-wide TrackWise administrator, train and assist users in TrackWise

Author, revise and approve Quality Systems’ SOPs

Audit manager of successful partner audit and participant in FDA audits including a successful PAI audit

Create yearly Quality Plan and ensure the monthly update and publication

Perform review of Annual Product Review documentation to remain in compliance with 21 CFR – Parts 210 & 211 Subpart J

Jan., 2008 – Arena Pharmaceuticals, Inc. San Diego, CA

Mar., 2013 Quality Management Systems Associate Manager

Manage the document structure in OpenText Livelink for submission of relevant documentation for the New Drug Application (NDA) and Investigational New Drug (IND) Application resulting in FDA approval.

Lead and manage contractors in the gathering of User Requirements and configuration workflows in TrackWise to include GMP Internal & External Audits, GLP Audits and GCP Site Audits & Vendor Audit Workflows, along with the implementation, validation, administration and training of TrackWise

Project Manager responsible for gathering User Requirements for configuration of the Product Complaints workflow in preparation of commercial drug approval

Project Manager for the creation and implementation of Global Computer System Validation program between Arena, San Diego and Arena, GmbH (Switzerland)

Aug., 2007 – Genentech (formerly Tanox, Inc.) San Diego, CA

Nov., 2007 Quality Associate

Quality Assurance Tech Transfer Team Member

June, 2006 – Tanox, Inc. San Diego, CA

Aug., 2007 Quality Associate

Review and route Manufacturing documentation

New employee GMP Training

Oct., 2005 – Amylin Pharmaceuticals, Inc. San Diego, CA

June, 2006 Quality Validation Document Associate

Administrator of Open Text Livelink for the Validation department.

Create and Maintain Validation documentation filing system

April, 2005 – SAVI Consulting – Amylin Pharmaceuticals, Inc. San Diego, CA

Oct., 2005 Validation / Metrology Associate

Review and routing of Validation & Metrology documentation

Maintain Blue Mountain for Metrology schedule

Jan., 2005 – Randstad – Biogen Idec Pharmaceuticals Oceanside, CA

Mar., 2005 Validation Document Control

Review and routing validation documentation for approval

Jun., 2002 – Isis Pharmaceuticals, Inc. – Ionis Pharmaceuticals, Inc. Carlsbad, CA

Jan., 2005 Quality Assurance Systems Coordinator

Implementation and system administrator of Qumas e-DocCompliance

Company-wide Qumas e-DocCompliance Training Program

Jan., 1991 – Scripps Memorial Hospital La Jolla, CA

Sep., 1997 Employee Health, Emergency / Trauma

Manage the Worker Compensation system for Scripps LJ and Scripps Green

Perform new employee physicals, drug screens

Provide training for North County, San Diego Paramedics

Compile and distribute paramedic and trauma metrics to hospital management

Contact this candidate