SUMMARY:

• Validation : Computer system validation at DePuy Synthes as QA Analyst writing UAT tests, at Confidential executing/peer review of EtQ system test scripts under FDA Consent Decree, at Confidential Informatics R&D Division while performing Quality Management duties for FDA regulated IT applications.
• Writing and reviewing system test scripts - IT applications, GRQP - JD Edwards interface validation: SAP, BizTalk, BI database tables, field equipment and quote tracking systems, etc.
• Writing Validation reports for software lifecycle projects, retirements, regulated process validation (non-conformances, etc.) for 21 CFR Part 11 compliance, cGDP, etc.
• Developing test cases for regulated retirement and migration processes, e.g., Confidential ’s Global Product Repository (GPR), Power to Learn (P2L), etc.
• Risk assessment - Experience tailoring project deliverables based on risk
• Writing of final project deliverables at Confidential compliant for GMP:
• Validation Reports for (P2L) v7.5 upgrade project.
• Validation reports for Confidential ReMArc (Retirement, Migration and Archival) projects
• Quality Assurance: Created and maintained regulatory compliant Quality Management Systems (QMS) for medical device industry, including current Good Manufacturing Practices (cGMP):
• Confidential Inc.
• Viatronix Inc.
• Confidential .
• IFI
• Quality Management - Created Software Life Cycle (SLC) processes for medical device companies and SLC consultant at Confidential R&D Division Worldwide Technologies Quality and Risk Management (Q&RM) group in New London/Groton, CT.
• Certified Internal Quality Auditor (accredited by RAB 5/18/05), ISO 13485 for medical device companies.
• Technical Writing:
• Created end-user product manuals for medical device companies
• Quality Assurance technical documentation
• ISO 9000 procedures/work instructions
• Validation documentation, calibration procedures, and other technical manuals.
• Created user approval tests (UATs), test scripts, QA function at Confidential and Depuy Synthes
• Previous IT experience:
• Computer and Systems Programmer (FORTRAN, BASIC) at Otis Engineering (now Halliburton Pressure Services).
• Computer technology: Technology Coordinator for Eastport School District, New York.
• Lotus Notes ® Administrator
• Databases management software (MS Access ® , Lotus Notes ® . Etc.)
• Quality Manager for IT software/hardware companies
• Supervisory: Managed QA department w/10-20 employees
• Teaching/Training - Classes taught:
• Business Communications at college level
• Adult Education classes in personal computing, MS Windows 95 ® , etc.
• Industrial blueprint reading for Xerox Corp.
• ISO 9000 procedural training
• Creative and Technical writing

PROFESSIONAL EXPERIENCE:

Confidential - Philadelphia, PA

QA Consultant

Work on Software Lifecycle deliverables, Requirements, Design and other process documents.

Confidential, Norristown, PA

QA Consultant

Consulting company - Client: Teva Pharmaceuticals, North Wales, PA

Create Test Plans based on Business and Functional requirements; create test cases/scripts for System Testing and User Testing (UATs); create traceability matrix for project deliverable.

Confidential, West Chester, PA

QA Analyst

Contracted through: Contemporary Staffing Solutions, Inc., Media PA

Computer system validation (CSV) and documentation per cGDP: Analyzed software requirements to create UAT and System test scripts for IT applications under standard project management, software lifecycle (SLC) and Agile software development methodologies. Developed acceptance criteria, test cases, traceability matrix, formal validation, review, etc. Projects included: GRQP validation of JD Edwards interface with BI and SAP-ERP - eSIMs, ePOR, BizTalk, etc.

Confidential, Fort Washington, PA

CSV Test Executor

Contracted through: Validant, San Francisco, CA

Conducted computer system validation (CSV) testing for FDA Consent Decree remediation; test script and peer review (cGDP) for EtQ modules and GxP regulated applications. Worked closely with Quality regarding GMP validation issues.

Sabbatical to write a book, published in 2015.

Confidential

Senior Quality Consultant

Contracted through: Keane, Inc., Corporate Headquarters, Boston MA

Provided support/consultation and management for various projects - managed Software Life Cycle (SLC) deliverables for Confidential Informatics R&D Division. Performed compliance audits per FDA cGxP requirements of application migration/retirement project deliverables and documentation; created Compliance Reports for project closure.

Confidential

Quality Assurance/Regulatory Affairs Manager and Technical Writer

Developed and maintained compliant Quality Management System (QMS) for ISO/FDA/CE conformance and certification. Created/wrote and maintained all user manuals for medical infrared imaging product; created and maintained company marketing documentation and information.

Confidential , Stony Brook, NY

Technical Writer

Created, wrote and maintained all user manuals for medical imaging software products, including virtual colonoscopy, heart calcium scoring and general volumetric imaging software; wrote and maintained all QMS documentation for FDA and ISO 9001 certification; created and maintained company (internal) Intranet for in-house documentation and information; created and maintained FDA approved product labeling.

Confidential , Ronkonkoma, NY

Quality Assurance Manager

Telecommunications software/service provider: Responsible for Quality Assurance department, writing ISO 9000 procedures, test plans and auditing procedures, departmental goals, personnel reviews and interviewing new employees.