Senior Software Validation Analyst Resume

TECHNICAL SKILLS:

EXPERIENCE:

Confidential

Senior Software Validation Analyst

Responsibilities:

Responsible for review/updating of the following Design History File ( Confidential ) documents for the medical devices produced & used in cervical, thoracic & lumbar spinal surgical procedures to verify compliance with CFR 21-Part 11, CFR 21-Part 820, Confidential -13485 & GxP regulations:
Risk Management Report - Risk Management Plan dFMEA - Design Input/Output Validation (DIOVV) Surgical Technique Guide (STG) - Instructions For Use (IFU) Bill Of Materials (BOM) - Device Master Record (DMR)

Confidential

Senior Software Quality Engineer

Responsibilities:

Responsible for review of all new IT Change Request forms and management of the IT Change Request Database.
Wrote Validation Plans to prove compliance with Confidential -13485 & GxP regulations for the following projects:
Electronic Data Interface (EDI)/GHX Database
IT Change Request Database
Unpacking Tissue Database

Confidential

Validation Verification Analyst

Responsibilities:

Executed the IQ/OQ/PQ Test Plan for the Confidential Triage Meter & Confidential Triage Meter Pro immunoassay diagnostic testing hardware devices to prove compliance with CFR 21-Part 11, CFR 21-Part 820, Confidential -13485 & GxP regulations.
Wrote the Validation Summary Test report that documents the IQ/OQ/PQ test findings & results for both devices.
Reviewed the Design History File ( Confidential ) documents for the twelve different software releases from 2001 to 2010 that provide information for diagnostic tests for infectious diseases, cardiometabolic diseases & toxicology. Created binders per software release for the following project phases:
Software Development - Software Design Change - Risk Management - Regulatory Software Verification - Design Validation - Product Release - Traceability Matrix

Confidential

Senior Verification Validation Analyst

Responsibilities:

Responsible for review/updating of the following Design History File ( Confidential ) documents for the Knee, Hip and Elbow replacement product lines to verify compliance with CFR 21-Part 11, CFR 21-Part 820, Confidential -13485 & GxP regulations:
User Requirement Specification (URS) - Trace Matrix (TM) Installation Qualification (IQ) - Operational Qualification (OQ) Performance Qualification (PQ) - Validation Summary Report (VSR)

Confidential

Senior Validation Analyst

Responsibilities:

Provide/manage all in Sprint validation documentation compliance/performance reviews for the following documents per product (in conformance with CFR 21-Part 11, CFR 21-Part 820, Confidential -13485 & GxP regulations) created by three Scrum teams using Agile/Software Development Life Cycle (SDLC) methodology:
Design Specification (DS) - Functional Requirement Specifications (FRS) User Requirement Specification (URS) - Installation Qualification (IQ) Operational Qualification (OQ) - Performance Qualification (PQ)

Confidential

Senior Validation/QA Analyst

Responsibilities:

Responsible for updating External Audit files for 2013, 2014 and 2015 to prepare (pre-auditing) for an upcoming Confidential Audit to verify compliance with CFR 21-Part 11, CFR 21-Part 820, Confidential -13485 & GxP regulations.
Wrote User Requirements, Test Plan and Reference User Guide for the Audit Tracking Tool.
Tested changes made to the Audit Tracking Tool and provided Validation Findings Summary Report.

Confidential

Senior QA/Validation Analyst

Responsibilities:

Wrote the User Requirement Specification (URS) and Installation Qualification/Operational Qualification (IQ/OQ) documents for the Vial Filler, Vial Elevator, Feeder, Pucker and the Vial Capper systems used by the production line 75 to produce/package Nicotine Mini Lozenges at the Confidential facility in Aiken, SC.
Responsible for execution of IQ/OQ documents, Error Tracking and writing of the Validation Summary Reports.

Confidential

Senior Validation Analyst

Responsibilities:

Assigned to the CAPA project to update/revise documents used in the Work Inspection Process for products created by the company.
The company manufactures instruments, implants and biological materials used for the surgical correction and regeneration of the human skeleton/soft tissues.
Responsible for updating Work Instructions and Standard Operating Procedure (SOP) documents for users in the USA and European Union.