jennifer scott

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Jennifer Scott 119 NE Greystone Dr. Lee’s Summit, MO 64086 816-804-8258 [email protected] Professional November ’10 - present Aptuit/Catalent Kansas City, MO Experience Senior Specialist, Quality Assurance- Clinical Supply Services Quality Specialist I/II Quality Assurance- Clinical Packaging and Logistics Daily Packaging In-Process Audits of cGMP materials Packaging Record Pre Approval Packaging Record Post Review Review of Certificates of Analysis for Packaging Components Label review and release QA Log-in of documents for Review Packaging and Logistics Weekly Facility Audits Meets deadlines according to agreed timeframes and communicated adjustments as needed Practice and follow GMPs, SOPs, SEPs and SIPs Communicates clearly with internal and external clients Maintain in-house, client and ID sample retains for future QA reference Approve clinical studies for release February ‘07 – November ’10 Aptuit Kansas City, MO Sr. Operator /Operational Compliance and Process Improvement Associate/ Clinical Packaging and Logistics Establish and maintain the training program for Clinical Packaging and Logistics Provide continuous training to the CP&L organization Manage and track training records for all CP&L employees Develop and maintain appropriate, effective training module Develop competency assessments for procedures Maintain metrics as established by Management Manufacture and package clinical, non-clinical and stability drugs

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Page 1: Jennifer Scott

Jennifer Scott119 NE Greystone Dr.

Lee’s Summit, MO 64086816-804-8258

[email protected]

Professional November ’10 - present Aptuit/Catalent Kansas City, MO Experience Senior Specialist, Quality Assurance- Clinical Supply Services

Quality Specialist I/II Quality Assurance- Clinical Packaging and Logistics Daily Packaging In-Process Audits of cGMP materials Packaging Record Pre Approval Packaging Record Post Review Review of Certificates of Analysis for Packaging Components Label review and release QA Log-in of documents for Review Packaging and Logistics Weekly Facility Audits Meets deadlines according to agreed timeframes and communicated

adjustments as needed Practice and follow GMPs, SOPs, SEPs and SIPs Communicates clearly with internal and external clients Maintain in-house, client and ID sample retains for future QA reference Approve clinical studies for release

February ‘07 – November ’10 Aptuit Kansas City, MOSr. Operator /Operational Compliance and Process ImprovementAssociate/ Clinical Packaging and Logistics Establish and maintain the training program for Clinical Packaging and

Logistics Provide continuous training to the CP&L organization Manage and track training records for all CP&L employees Develop and maintain appropriate, effective training module Develop competency assessments for procedures Maintain metrics as established by Management Manufacture and package clinical, non-clinical and stability drugs Ability to lead jobs pertaining to label and assembly, hand filling, unit dose

cards, and controlled substances Create patient kits for clinical trials Work with the randomization and blinding of patient kits Verify accuracy and completion related to jobs Apply patient specific and drug specific labels Practice and follow GMPs, SOPs, SEPs and SIPs Create unit dose cards and blister packs Fill and seal bottles both by hand and by machine

Page 2: Jennifer Scott

August ’08 – January ‘13 Hope House Lee’s Summit, MO Women’s Advocate

May’08 – August ’08Practicum Student Answer the hotline and provide appropriate resources to callers. Provide primary coverage at the shelter front desk. Demonstrate knowledge of domestic violence. Provide effective crisis intervention with individuals requesting assistance. Assists clients with emergency and non emergency orders of protection. Complete intakes for new arrivals and orient new residents. Maintain confidentiality and appropriate boundaries with shelter residents at

all times. Support the development of problem-solving and conflict resolution skills

with shelter residents. Provides ongoing case management and support to clients through meetings

and regular contact to focus on client-identified goals and needs.

April ’06 – February ‘07 Kelly Services (Aptuit) Kansas City, MOAssociate/ Clinical Packaging and Logistics Manufacture and package clinical, non-clinical and stability drugs Create patient kits for clinical trials Work with the randomization and blinding of patient kits Verify accuracy and completion related to jobs Apply patient specific and drug specific labels Practice and follow GMPs, SOPs, SEPs and SIPs Create unit dose cards and blister packs Fill and seal bottles both by hand and by machine

Aug. ’05 – Dec. ‘05 Carondelet Manor Kansas City, MOPracticum Student Resolving resident issues; calling families Mini-mental status exams Resident social histories Attending family care plan meetings Medical records; chart filing; scheduling transportation and MSDs

2002 – 2005 Qualex Lee’s Summit, MOManager Inventory; ordering; daily financial spreadsheets Scheduling; filing; organizing; customer service; telephone calls; cash

handling Everything involved in processing and printing film HSE trained and certified; chemical mixing Light maintenance; technical troubleshooting and quality control

Education 2008 / Bachelor’s degree / University of Central Missouri2006 / Associate’s degree / Longview Community College

1994 / Graduate / Center High School

Organizations 2008 / Member National Association of Social Workers 2008 / Treasurer Association of Social Work Students 2007 / Junior Representative Association of Social Work Students