Bio
Credentials
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GMP QMS 8-HR FromAuditor's perspective
GMP QMSFromAuditor's perspectiveNov, 2021- Apr, 2026 -
August 2003, US FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application
Azzur GroupOct, 2021- Apr, 2026 -
Data Integrity and Compliance ALCOA+
Azzur GroupOct, 2021- Apr, 2026 -
GLB-VAL-0001 v.3.0, Global Validation Program
Azzur GroupSep, 2021- Apr, 2026
Experience
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Azzur Group
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Hatboro, Pennsylvania, United States
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Consultant 3
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Oct 2021 - Present
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Hatboro, Pennsylvania, United States
Pharmaceutical Industry Consultant, Level 3
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Lower Merion Library System
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Lower Merion, Pennsylvania, United States
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Technology Librarian
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Jan 2015 - Sep 2021
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Lower Merion, Pennsylvania, United States
As technology librarian, I was a member of Management Team & Strategic Planning Team. LMLS WordPress website webmaster. Maintain staff and public PCs at 8 locations. Create statistical reports using database tools and Excel. Implement new technologies. Write operational procedures and training guides. Train staff on technology. Office 365 and Google G-Suite admin. Assist patrons and train them on public computers or their own devices.
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LIbrarian / Bookkeeper / Webmaster
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Dec 2002 - Dec 2014
Worked 30 hours per week, Monday through Friday, while my kids were in school. Purchased and cataloged new items in the library database. Created monthly statistical reports using database reporting tools and expertise with MS Excel. Keep books and budgets with Quicken. Designed a WordPress website. Wrote training guides. Trained staff. Worked with the library board.
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First Consulting Group/ISCG
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Wayne, Pennsylvania, United States
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Computer Consultant, Pharmaceutical Industry EDMS
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Mar 1997 - Nov 1998
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Wayne, Pennsylvania, United States
Project management and quality assurance/validation testing for customizations to McNeil Pharmaceuticals EDMS document management (Documentum) software. Wrote functional specifications and test scripts. Ran test scripts to validate changes to Documentum customizations. Worked closely with programmers. Was liaison with pharmaceutical company staff. Resigned to be a stay-at-home mother.
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Wyeth-Ayerst Research
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Radnor, Pennsylvania, United States
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Senior Analyst, Global Information Management
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Mar 1993 - Mar 1997
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Radnor, Pennsylvania, United States
Electronic Regulatory Systems (ERS) project coordinator. The large multi-disciplinary project included database, text and imaging teams. Wrote project proposals, functional specifications, test plans, user acceptance and validation documentation for several application development projects. Trained all users of the ERS at Wyeth Ayerst Research, the FDA and the Canadian HPB. Played major role in creating, implementing and expanding ERS, Electronic Publishing, Document Management, Knowledge Management and WAR Intranet. Led the beta testing pilot program that established the Electronic Publishing department and the WAR Intranet. Supported Documentum. Created web pages as part of DREW, Wyeth’s first Documentum Web interface. Participated in departmental budget planning. Supported systems with expertise in MS Office, HTML, Adobe Acrobat products. Acted as liaison with Adobe, Xerox and other software vendors.
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RDC Research Data Corporation
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Haddonfield, New Jersey, United States
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Database Design / Project Coordinator
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Nov 1991 - Mar 1993
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Haddonfield, New Jersey, United States
Designed CANDA database specifications and screens. Liaison with Pharmaceutical Company Clients developing first electronic regulatory submissions to the FDA. Wrote and presented paper at DIA March 1993
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Education
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Clarion University of Pennsylvania
Master's degree -
Penn State University
Bachelor's degree -
Cardinal O'Hara HS
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