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Data Entry Document Control

Location:
San Diego, CA
Posted:
April 30, 2019

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Resume:

Vanessa Loughrey

**** ********* ****

Chula Vista, California 91915

858-***-****

*******.********@*******.***

EXPERIENCE:

August 2016-Present: Student Intern: Agnes Zim Consulting Services (BioTech Clinical Trials Consultant), San Diego, CA

oReviewed GXP Documents and for their completeness and accuracy.

oEdited, reviewed, and reformat Clinical Audit Reports for authors in to establish consistency within the text.

oKnowledgeable in coding 21 CFR (Parts 50, 54, 56, 312 and ICH E6(2) References, as well as applying the information to Clinical Site Observation Reports.

2014 Summer Intern: Arena Pharmaceuticals, 6154 Nancy Ridge Drive, SD, CA 92121

oAssisted in the Arena Quality Assurance Document Control transferring GxP documents to external vendor.

oMaintained inventory for GxP (GLP, GCP, cGMP) records for completeness prior to transferring GxP documents to the external vendor for permanent storage.

oPerformed Document Control activities such as, document review and approval, data entry, filing, maintaining logs, processing documents, scanning documents. As well as, ensuring records were verifiable, complete, and accurate.

oSupported the Arena Quality Assurance department in implementing electronic repository system and maintaining a compliant Quality System internal SOPs

oAssisted in processing document change requests and coordinating the approval of SOPs, Work Instructions and Forms

September-November 2018: San Jose Area Writing Project

oI am knowledgeable in conducting warm up writing exercises for students grades k-12.

oOffered support to guest speakers by coordinating and maintaining a professional teaching environment.

oResponsible for ensuring students fully comprehended the writing assignment, as well as provided extra support when needed.

oWorked closely with students of various ages and writing skills in a group or individual setting.

SKILLS & ABILITIES

My skills and abilities include being dedicated to producing efficient results.

I am neat, efficient and thorough within the content of my writing and editing, as well in my organizational skills.

I have the ability to work in fast paced environments.

I am a goal orientated person who uses critical thinking and analysis within all projects with excellent rhetorical and oral communication skills.

I have knowledge in MS Word, MS Outlook, MS PowerPoint and Internet. As well as experience with an electronic document or information management systems.

EDUCATION:

•BA English San Jose State University (2014-2018)



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