Erich Walrath's Location
Minneapolis, Minnesota, United States, United States
Erich Walrath's Contact Details
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About Erich Walrath
Objective: Challenging position as software quality specialist with focus on pharmaceutical or medical device systems and infrastructure Quality Assurance: Seasoned software quality specialist with focus on computer systems and infrastructure. Quality System: Strong familiarity with CFR 21, Part 820 and CFR 21, Part 11Authored Software Development Life Cycle standards. Experienced in all aspects of the Software Development Life Cycle (SDLC) including: design, development, testing, deployment, and maintenance. Developed and implemented Corrective and Preventative Actions (CAPA). Developed and implemented software discrepancy tracking process.Actively reviewed Quality System to ensure compliance and for areas of improvement and efficiency.Project Management: Managed system validation organizations of up to 20 resources. Lead cross-functional teams on business critical validation projects.Software Testing: Experienced QA tester with a strong pharmaceutical and medical device background. Managed software testing efforts on business critical systems.Validation: Authored, implemented, and executed validation plans, system requirement specifications, test plans, test cases, test reports, validation reports, and other validation deliverables.Authored and implemented system Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Documentation: Author of Standard Operating Procedures and policies. Authored validation artifacts inclusive of plans, requirements, test scripts, and reports.Strong familiarity with Good Documentation Practices (GDP).Training: Developed and led training on quality systems.
Erich Walrath Work Experience Details
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Senior Software Quality Assurance EngineerAcist Medical Systems Oct 2021 - PresentEden Prairie, Mn, UsPosition supports the development, validation, implementation, and maintenance of Quality System software. Also responsible for owning and maintaining processes to appropriately control and validate Quality System software applications, oversee and manage validation activities and documentation for all Quality Management System (QMS) applications. As a system analyst this role analyzes, develops, and maintains QMS applications and implements configuration changes and improvements. -
Sr. Computer Systems Validation ConsutantScientific Protein Laboratories, Llc Feb 2021 - Jul 2021Waunakee, Wisconsin, Us• Identified gaps in validation documentation for existing lab equipment.• Created and implemented necessary documentation in alignment with CFR 21 Part 820 and CFR 21 Part 11.• Responsible for authoring:o Validation Plan o Data Integrity Plano Risk Management Plano User Requirementso Functional Requirementso Installation Qualification Protocolo Operational Qualification Protocolo Validation Summary Report• Performed quality review on executed protocols.• Ensured that GxP documentation complied with current processes and procedures. • Provided input into a standardized set of validation deliverables to be utilized across the company, along with accompanying roles and responsibilities for reference in the corporate quality process. -
Sr. Computer Systems Validation ConsultantSeagen Mar 2020 - Nov 2020Bothell, Washington, Us• Tracked and performed review of electronic records related to GxP assets. • Performed gap analyses against available documentation. • Ensured that GxP documentation complied with current processes and procedures. • Performed periodic reviews of manufacturing equipment. • Identified a standardized set of validation deliverables to be utilized across the company, along with accompanying roles and responsibilities for reference in the corporate quality process.• Position utilized CMMS and EMS systems in support of GMP Equipment management -
Computer System Validation ConsultantAlcami Corporation Nov 2019 - Feb 2020Wilmington, Nc, Us• Decommissioned laboratory software systems for an analytical lab doing microbiological and chem testing.• Assessed equipment, to ensure proper data integrity.• Obtained final backup of systems.• Identified and dispositioned all CSV documentation pertaining to decommissioned systems. -
Senior Computer System Validation EngineerPtc Therapeutics, Inc. Apr 2019 - Oct 2019UsValidation Lead for implementation of document management system for clinical trials.Authored Computer Systems Validation SOP and supporting documents covering validation requirements for both bespoke and COTS systems.Developed forms for Quality Documents department to standardize development of SOPs. -
Sr. Computer Validation ConsultantTeleflex Incorporated Nov 2018 - Dec 2018Wayne, Pa, UsConducted successful audit readiness for product quality test equipment:• Served as a consultant in preparation for an imminent audit.• Authored critical validation documentation in conformance with company SDLC.• Performed Installation Qualification and Operational Qualification testing.• Provided documentation and other support during audit. -
Sr. Computer Validation ConsultantPhilips Dec 2017 - Nov 2018Amsterdam, Noord-Holland, Nl• Full remediation of manufacturing line including rectification of GxP issues.• Identification of requirements for process validation.• Risk assessment of existing systems where previous efforts were demonstrated to be inadequate.• Gap analysis of system validation against existing and proposed quality system processes and procedures.• Authoring of validation plans, installation qualifications, operational qualifications, and performance qualifications for full and incremental validation efforts. -
Sr. Computer Validation ConsultantArthrex Jan 2017 - Sep 2017Naples, Florida, Us• Supported introduction of computerized system for automation of design, review and approval, and printing of labels.• Authored project Validation Plan.• Performed and documented risk assessment in PFMEA.• Created business requirements and supported the identification of functional requirements.• Created test cases for performance qualification with full traceability to the business requirements.• Authored work instruction governing the process of label review and approval.• Created system configuration specification.• Managed document tracking for mission critical documentation -
Sr. Computer Validation ConsultantMerck Aug 2016 - Dec 2016Rahway, New Jersey, UsPerformed requirements identification, installation qualification, and operational qualification on automated tube-filler system for the Quality Operations Lab. -
Sr. Software Validation ConsultantBausch + Lomb Jan 2016 - Mar 2016Bridgewater, Nj, UsRemediated system documentation in preparation for regulatory scrutiny. Evaluated, and updated existing traceability matrices. Created new traceability matrices as needed. Developed a comprehensive and exhaustive approach to the task that included identification of legacy documentation. Assured that systems would be defendable under the client’s quality system. -
Senior Software Validation ConsultantBlack Diamond Networks Mar 2015 - May 2015Andover, Massachusetts, UsIdentified user and functional requirements for complex MS Access application utilizing SQL Server, inclusive of system design specification. Created end-to-end validation protocols including unit, as well as functional and user tests. -
Senior ConsultantMedtronic Apr 2014 - Oct 2014Minneapolis, Mn, UsPerformed risk-based validation remediation on legacy systems. Authored, reviewed, and approved validation deliverables. -
Sr. Software Quality EngineerBoston Scientific Corporation 2005 - Nov 2013Marlborough, Ma, UsDirected team of Software Quality Engineers in completion the validation activities for automated manufacturing lines. Developed and implemented Automated Instrument Qualification validation process.Developed and implemented the departmental Discrepancy Process. Developed and executed Corrective and Preventative Action plans.Identified legacy systems throughout site in need of remediation. Provided oversight for remediation effort.Provided project direction, coaching, and mentoring for the quality systems team personnel. Developed and led training in the use of Software Development Life Cycles as well as Discrepancy Process.Authored documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations CFR 21, part 11 and CFR 21, 820.Proactively investigated, identified, and implemented best in class Quality System practices.Provided on-site support for implementation of business critical manufacturing line for sites in both Maple Grove MN. and Galway, Ireland.Authored and implemented full validation package for sterilization system, on-site in Coventry, RI. -
Senior Software Quality ConsultantBoston Scientific Corporation 2004 - 2005Marlborough, Ma, UsSoftware validation specialist engaged in defining and delivering corporate-wide standard for Software Development Life Cycle (SDLC). Implemented the standard on business critical application for business critical electronic data capture application.
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Systems Validation ConsultantEli Lilly & Company 2002 - 2003Indianapolis, Indiana, UsAuthored documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21, part 11. Performed Electronic Record / Electronic Signature remediation assessment on GMP systems. Authored departmental Standard Operating Procedures (SOPs) governing code migration, system security, record retention, and document management. Managed departmental deliverables that were identified in company GMP Gap Analyses and other assessments. Designed and Implemented tools to track and manage status of GMP related documentation. Responsible for system test documentation, including test plan, tracability matrix, and test result reports. -
Systems Validation ConsultantComplete Software Solutions 2001 - 2002Reviewed, edited, or authored multiple validation related documentation for clients of a computer systems validation consultancy. Authored internal SOPs concerning IQ, OQ, and PQ processes. Organized and performed validation testing on internal systems.
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Manager Of Computer System ValidationGenentech Inc. 1997 - 2000South San Francisco, California, UsManager of multiple teams conducting comprehensive end-to-end software testing of large systems for clinical trials including adverse event tracking, clinical trial resource management, clinical trial results tracking, reporting and statistical packages. Systems included Oracle Clinical 7, Clintrace, and in-house developed applications. Manager of overall software quality assurance effort including the documentation of validation/verification efforts to demonstrate compliance with internal operating procedures, as well as federal regulations. Provided oversight for all IQ, OQ, and PQ activities. Implemented and managed Change Control system. Chaired change control board for IT organization; assessed both impact and validation requirements for systems. Developed and implemented software testing methodology to be utilized on business critical applications . -
Software Quality Assurance ConsultantCharles Schwab & Co. 1995 - 1997Westlake, Texas, UsQA lead for executive information system development effort. Mission was to implement rigorous and exhaustive testing of a full-featured Client-Server system. Technical manager of team conducting white-box and black box testing of complex Web-based Java application. Manage temporary teams of up to 5 testers on multiple projects. -
Quality Assurance ConsultantRoche Corporation 1994 - 1995Responsible for Quality Assurance testing of in-house developed Adverse Event Tracking application as well as reports. Testing included both "black box" and "white box" approaches. Responsible for the creation of functional specification documents for Clinical Investigator Tracking and Adverse Event Tracking applications. Participated as both programmer and Quality Assurance Engineer in the development of complex Clinical systems. Authored underlying documentation; testing training materials; created initial prototype of Research Desktop application: (an interface to a set of inter-related systems).
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Project ConsultantBlyth Software Inc. 1989 - 1993Plymouth, Massachusetts, UsConsultant to Fortune 500 clients for system analysis, design, project management and/or development, and knowledge transfer. Trained large groups, spanning a wide range of technical expertise, in all aspects of a complex database system. Managed a team of technical support engineers. Complete support included tracking bugs, reviewing client code for errors, recommending enhancements, and managing upgrades. Designed, developed, deployed, and maintained reusable code, templates, and other tools for use with a variety of variety of RDBMS technologies. -
Data Communications SpecialistGoldman Sachs & Co. 1985 - 1989New York, New York, UsDeveloped systems for computer aided analysis of financial data for a regional Fixed Income department of major investment bank. Responsible for transmitting transactions to central office in New York City. Participated in the design of our in-house database.
Erich Walrath Skills
Quality Assurance
Testing
Software Documentation
Computer System Validation
Validation
Fda
Software Quality Assurance
Sdlc
Quality System
Medical Devices
Change Control
21 Cfr Part 11
Capa
V&v
Quality Management
Cross Functional Team Leadership
Test Planning
Databases
Management
Iso 13485
Process Improvement
Quality Auditing
Technical Writing
System Testing
Software Development
Pharmaceutical Industry
Gxp
Manufacturing
Root Cause Analysis
Requirements Analysis
Six Sigma
Business Analysis
Process Simulation
Sop
Resource Management
Automation
User Acceptance Testing
Gap Analysis
Agile Methodologies
Training
Software Quality
Scrum
Oracle
Test Automation
Lims
Product Development
Software Engineering
Metrics
Program Management
Internal Audit
Erich Walrath Education Details
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San Francisco State UniversityEnglish -
San Francisco State UniversityEnglish: (Emphasis In Linguistics)
Frequently Asked Questions about Erich Walrath
What company does Erich Walrath work for?
Erich Walrath works for Acist Medical Systems
What is Erich Walrath's role at the current company?
Erich Walrath's current role is Software Quality Assurance.
What is Erich Walrath's email address?
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What schools did Erich Walrath attend?
Erich Walrath attended San Francisco State University, San Francisco State University.
What are some of Erich Walrath's interests?
Erich Walrath has interest in Human Rights, Science And Technology, Education.
What skills is Erich Walrath known for?
Erich Walrath has skills like Quality Assurance, Testing, Software Documentation, Computer System Validation, Validation, Fda, Software Quality Assurance, Sdlc, Quality System, Medical Devices, Change Control, 21 Cfr Part 11.
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