Summary of Qualifications

Twenty plus years’ experience as a QA lead and validation coordinator (internal/external)

Supervised the team to assure SDLC/ISO 13485 documentation changes

Managed internal/external manufacturing teams developing change processes

Precision system testing, troubleshooting/tracking of data for PLM system

Meticulous attention and proficiency in SDLC, inspires obtainable goals and target reports

Assisted line organizations with procedure issues/formulating cGxP procedures

Developed technical specification sheets, inserts, SOPs, WIs, MPIs, BSE/TSE statements

I would like to utilize my qualities for helping people and managing medical patients for better health, documenting activities with timely executions, organized patient-focused, and my knowledge of culture diversity, efficiency and communication skills.

Experience

Coordinated quality project timelines across platforms and continued process oversight

Reviewed proposed changes for impact, integrated materials to receive compliance approvals

Organized and wrote supporting documents and revised documents per current issues

Coordinated global documentation changes, designs, reviews, and storage guidelines

Tracked document changes/required revision actions within EDMS or PLM systems

Perfected Visio charts, PDF’s, photographs, drawings, diagrams to increase understanding

Maintained team relations with global suppliers to ensure Quality Control/Compliance

CM Certifications

Certified Technical writer from University of Phoenix (UOP)

Agile Administrator – 1997, 2001, Agile Change Cast 2000, SAP R3 certified 1998

ISO 9000, 13485, Certified 2003, GMP Certified 2006, GLP Certified 2007 GXP Certified 2009

Core Strengths

Configured Compliance Wire for training curriculums

EDMS Documentum, Master Control, certificates of BSE/TSE statements

ADAPTIV PLM change management software

Agile PLM Database 1.0 through 9.3, Intuitive ERP Client 8.1,

PPM – Project Portfolio Management, PC – Product Collaboration, Validation Core Team

ERP/MRP Systems – SAP R3, MAXIM, QAD – MFG/PRO, JD Edwards, ASK MANMAN

Process of IQ/OQ/PQ, ISO 9000, 9001, 9002/13485, 21CFR820 QSR

MS Office 2016: Word, Excel, Access, SharePoint, PPT, VISIO 2013, MC OneNote

PROFESSIONAL EXPERIENCES

Clinical and Validation Coordinator

NeoRX Corporation (Poniard Pharmaceuticals), San Francisco, CA 03/2019 – 08/2020

Prioritized project timelines, interacted with clients, team meeting collaboration

Administrative support and research to clinical operations, pivot tables for SDLC

Managed maintenance of document storage on and off site, responsible for regulatory audits

Created and supervised document training and content, continency/compliance requirements

Operator coverage processing calls, researched incorrect/missing demographic information

Track Wise migrations and flow implementations, writing and reviewing controlled documents

Technical Writer and Editor

Terumo BCT, CO (ALKU Consulting) 12/2018 – 02/2019

Edited and rewrote medical training documents/SOPs tracked validation completions

Supplied input to technical changes and required training validation points

Created multiple Visio/PowerPoint documents for validation activities in training classes

Updated validation process in accordance with site schedule matrices

Scheduled regulatory appointments and documented requirements

Agile Change Management Analyst

Integra Life Sciences, PA (ALKU Consulting) 07/2018 – 12/2018

Agile validation analyst and document coordinator, wrote changes/BODs, tracked completions

Scheduled clinical trials, recorded data collections, validation reports, testing/inspection

Plant resources and suppliers, commandeered materials, conducted SDLC analysis reports

Writer/editor of FDA memo’s, PowerPoint presentations, risk/issue management reports

Coordinated changes and clinical trials on IFU (Instructions For Use)

Training and Change Coordinator

Immunomedics, NJ (American Contracting Group) 10/2017 – 06/2018

Developed a Performance Assessment form and the SOP for training/implementation

Implemented change projects, issued pivot tables and variance analysis reports

Training classes with all levels of organization, monitored analysis certificates

Created training material, documented gaps, rewritten/revised testing designs/implementation

Technical Change Writer (Online Documentation)

Wells Fargo Financial Services, NC (ettain consulting group) 08/2017 – 10/2017

Documented and coordinated new processes and MOSS digital screen changes

Collaborated with SMEs Developed and SDLC training materials for global documentation

Coordinated revision reviews by document owners of Global SOPs and document

Senior Quality Auditor

Copy Master Graphic Press, CA (remote consulting) 03/2016 – 08/2017

Proof first sheet press, front and back resignation, verification of bar code placement

Supervised visual inspection/clearances in manufacturing and production, audits use of PPE

Audits production performance/forms, assists manufacturing in quality standards

Quality Systems Coordinator/Change Management

Endo Pharmaceuticals, PA (Spectraforce Technologies) 03/2015 – 03/2016

Business Change Analyst/Master Control SDLC coordinator, change implementations

Responsible for internal quality processes, change requests, SOP’s, department training

Enter data into quality software system (LIMS), SOPs for validation processes

Trained system users in Master Control for ISO 9000 and 13485; IT, SOPs, MPIs and WIs

Project Coordinator/Technical Writer

DePuy Synthes - J&J division, PA (ALKU Consulting) 08/2013 – 12/2014

Wrote and tested ADAPTIV PLM user’s guide and tool evaluation procedures

Managed validation rewrite of complaint handling and adverse event reporting process

Defined and analyzed documents for language translation to outside sources

Change Coordinator MAP Pharmaceuticals, CA 03/2012 – 07/2013

Change Project Manager - Neurovascular, CA (Maetrics) 09/2011 – 02/2012

Documentation Manager Oraya Therapeutics, CA 06/2008 – 08/2011

Document Change Analyst, Boston Scientific, Fremont, CA 07/2006 – 05/2008

Document Control Manager, Allied Telesyn Inc., Sunnyvale, CA 05/2000 – 07/2006

Documentation Manager, Palm Computing Inc. San Jose, CA 10/1996 – 04/2000

Manager of Documentation, WYSE Technology, San Jose, CA 02/1985 – 09/1996

Education

BS degree in Communications/PMP Certification (University of Phoenix, candidate 2021)

AA Degree in Education, West Valley College, Saratoga, CA

Experience related certifications: CQA, CQE and CRE

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