Susan Caldwell work email
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Experienced quality assurance professional with a proven track record of producing high-quality, compliant documentation within the pharmaceutical/biotechnology industry.Recognized leader for developing quality systems and ensuring company compliance with industry and health authority regulations. Versatile, practical problem-solver with exceptional attention to detail, committed to meeting challenges of a fast-paced, deadline-driven environment.
Paradocx Vineyard
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Wine SpecialistParadocx Vineyard Jan 2008 - PresentKennett Square, PaServing and educating customers at wine bar, festivals, concerts and other events.
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Clinical Research CoordinatorWest Chester Cardiology Apr 2012 - Aug 2015West Chester, PaCRC for their present clinical trials. -
Associate Director Quality ControlPharmanet Development Group, Inc. Mar 1990 - Sep 2011•Led the day-to day operations of the Quality Control (QC) group, including scheduling of resources and conduction audits.•Supervised and mentored assigned QC staff.•Worked with approximately 22 different sponsors in the last year and performed QC of the following: 6 protocols, 9 case report forms, 8 data management plans, 9 databases, 12 statistical analysis plans, 10 statistical outputs, and 13 clinical study reports. •Coordinated and scheduled QC review and audit of Clinical Study Reports, study databases and statistical output (tables, listings and figures).•Wrote and maintained summaries or reports of QC review findings.•Coordinated generation, periodic review and approval of all QC SOPs, Policies and Operating Guides.•Assisted in preparation for sponsor audits.•Ensured resolution of issues identified during sponsor audits.•Presented QC services to prospective clients.•Provided guidance on Good Clinical Practices (GCP) compliance issues to project teams. -
Senior Manager Qa, And Qa ManagerPharmanet Development Group, Inc.(Formerly Sfbc Newdrug Services) Jan 1995 - Jan 2002Kennett Square, Pa•Managed clinical research project files in accordance with FDA guidelines and regulations and sponsor specifications.•Advised appropriate team personnel of regulatory deficiencies and monitored all incoming documents for impact on projects.•Arranged for the transfer of documents to sponsor/permanent storage at the completion of a contract.•Conducted QC review of all computerized databases of clinical trials data.•Edited documents and reports prepared by SFBC.•Conducted internal and external audits of clinical trials.•Evaluated clinical data for completeness and adherence to protocol, GCP guidelines and FDA regulations.
Susan Caldwell Skills
Susan Caldwell Education Details
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Physical Education -
West Nottingham Academy
Frequently Asked Questions about Susan Caldwell
What company does Susan Caldwell work for?
Susan Caldwell works for Paradocx Vineyard
What is Susan Caldwell's role at the current company?
Susan Caldwell's current role is Working at Paradocx Vineyard.
What is Susan Caldwell's email address?
Susan Caldwell's email address is sq****@****ast.net
What is Susan Caldwell's direct phone number?
Susan Caldwell's direct phone number is +161032*****
What schools did Susan Caldwell attend?
Susan Caldwell attended Tusculum College, West Nottingham Academy.
What are some of Susan Caldwell's interests?
Susan Caldwell has interest in Body Pump, Cooking, Reading, Zumba, Wine.
What skills is Susan Caldwell known for?
Susan Caldwell has skills like Clinical Research, Clinical Development, Sop, Project Management, Protocol, Cro, Fda, Edc, Gcp, Quality Assurance, Clinical Trials, Drug Development.
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Susan Caldwell
Southern Correspondent For The Donna Drake Show I Executive Producer At Lunchbox Heroes MediaUnited States -
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Susan Moran
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1kmfm.com -
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