Nursing Assistant Data Entry
Resume:
Patricia M. Gaddy
**************@*****.***
Professional Summary
Leadership responsibilities in regulatory operations within the pharmaceutical industry utilizing proven strengths in analysis, problem-solving, organization, follow-through, decision making and team building. My goal is to produce operational quality and efficiency to exceed customer expectations. Professional attributes include strong communication skills and an excellent record of achieving all goals through hard work and dedication.
Education
Richmond Community College Hamlet, NC 2001
AS, Information Systems Analyst
Professional Experience
GlaxoSmithKline RTP, NC 3/2009 – 11/19/2016, Due to Company Lay-off (At present taking care of sick family members while pursuing my next job opportunity.)
(Accentuate Staffing from 10/2008 -3/2009)
Regulatory Associate
Compliance checks: Evaluate and communicate discrepancies
Develop relationships with personnel in other functional areas (Le. marketing, publishing, safety, etc) Documents, Initial INDs and Original NDAs.
Filed regulatory documents including initial investigational new drug applications, amendments, and investigator updates. (INDs, NDAs, etc.).
Responsibilities included the filing, creation of new binders, and maintenance of product inventory spreadsheets, indexed and QA all paper submissions and eCTD submission electronic.
Scanned and converted documents to pdf using high speed scanner; Uploaded images into the company documentation system.
Trained and supervised new staff for prep documentation, converting documents to PDF for storage in company document system.
Redacted batch-file submissions to remove non-application specific documents in order to prepare file for Legal Operations Group.
Prepared inactive/withdrawn applications for off-site storage; Included documenting the contents and boxing on copy prep, scanning.
Comply with GSK records storage process to ensure transfer within three business days.
ACC Staffing (GlaxoSmithKline) RTP, NC. 2002-2006
Imaging Specialist
Utilize scanning equipment to convert hard copy documentation to digitized images.
Transmit images to optical disks contained within jukeboxes residing on the GSK IT network and or to magnetic media (Compact Disk) for distribution to customer groups.
Perform data entry for both digitized and microfilmed images to capture pertinent information about image, allowing automated search and retrieval of images in the future.
Maintains confidentiality of all production request; complies with GSK and IDS policies and standards
Completes daily production and time reporting records accurately and on-time.
Education
Richmond Community College, Hamlet, NC
1999 to 2001
AS in Information Systems Analyst
Robeson Technical College Lumberton, NC
1980 to 1980
Certification NC Nursing Assistant
Central Piedmont College Charlotte, NC
1978 to 1979
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