Quality Assurance Project Manager

Jasmine R. Davis

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

Willingboro, NJ 08046

Email: ***************@*******.***

Primary Cell: 609-***-****

Secondary Phone: 609-***-****

OBJECTIVE

I am seeking to obtain a clinical research assistant or data

management position within a Contract Reseach Organization, where I can

continue to gain experience in clinical quality processes while applying my

compliance and regulatory knowledge to the assigned position.

SUMMARY

I am a Quality Assurance professional with 5 years experience in the

pharmaceutical industry. Extensive current regulatory knowledge to ensure

standards of quality are maintained. I am looking to expand my career into

clinical trial arena. If you are seeking to hire an individual with an

extraordinary work ethic, geared toward effective communication through

team work and the passion to succeed while staying grounded, I strongly

encourage you to take a look at my qualifications below.

EDUCATION

Temple University, School of Pharmacy, Fort Washington, PA May 2010-

Present

Certificate of Drug Discovery leading towards a

M.S. Quality Assurance/Regulatory Affairs

Morgan State University, Baltimore,

MD 2001-2005

B.S. in Biology

Willingboro High School, Willingboro, NJ June 23, 2000

EXPERIENCE

WuXi AppTec Inc., Philadelphia, PA

Jan 2007 - Jul 2011

Quality Assurance Associate III/II

. Auditing of GLP and GMP batch records, validation/qualification,

reagent protocols and other associated testing material for GLP / cGMP

/ GTP compliance, and assuring that all specifications are met and

meet all FDA, EU and ICH guidelines and regulations.

. Inspect testing steps, evaluate discrepancies found during review and

determine appropriate action.

. Work closely with Laboratory Personnel to resolve open issues

resulting from batch record reviews, internal audits of the facility,

and deviation issues.

. Initiate and closes out of non-conformance, deviation and CAPA

reports.

. Assist Supervisor and Manager in procedures including SOP revisions,

batch record distribution and other departmental tasks when

appropriate.

. Manage departmental work load and distribution.

. Manage special projects as assigned.

. Maintain and update department databases for metric and RFT tracking.

. Responsible in assisting management in training of new and/or

untrained associates.

. Participate in internal and external client/vendor audits.

. Lean Sigma - Kaizen Quality Review team member

Quality Assurance Associate I

. Auditing of GLP and GMP batch records and other associated testing

material for GLP / cGMP / GTP compliance, and assuring that all

specifications are met and meet all FDA regulations.

. Complies and review raw data, batch record and test results, including

Final Reports in accordance with cGMP, GLP, Code of Federal

Regulations (CFR) guidelines and internal procedures.

. Perform archiving and other pertinent job related task.

. Perform internal auditing of laboratories

GlaxoSmithKline, Research and Development, King of Prussia, PA Jul 2006 -

Sep 2006

GMP Auditor (contract position)

. Cataloge documents to support its resource/research functionality.

. Documentation auditing.

. Organized data collected from varies documentation sources (TrackWise)

into a condense MS Excel documents to be used for GQA auditing

analysis.

. Analyzing documentation to evaluate historical data for authenticity;

tractability and integrity.

GlaxoSmithKline, GMS, King of Prussia, PA Mar 2006-

Apr 2006

Operational Excellence Associate (contract position)

. Assisted in an internal audit review.

. Evaluated data from Analytical laboratory notebooks and batch

records.

. Created spreadsheets using MS Excel to capture and compare results

from batch records and protocols.

. Organized data collected from varies documentation sources into a

condense MS Excel documents to be used for GQA auditing analysis.

. Following company's SOP regulations.

Xerimis, Inc., Moorestown, NJ

Jun 2005 - Dec 2005

Packaging Technician, Label Document Associate, Project Manager

Assistant (contract position)

. Primary and secondary packaging and labeling of pharmaceuticals in

clinical trials in accordance to FDA regulated cGMP and SOPs.

. Attended ongoing GMP and SOP training in accordance with FDA and

company regulations.

. Provide support in proofreading, randomization, accountability, and

pulling of labels.

. Assisted in PM with assembly of batch records, packaging samples, and

checklist sheets. Preparation of interoffice request.

. Performed full inventory and reconciliation of drug products.

. Experience working with refrigerated drug product.

SKILLS:

. Proficient in: MS Word, MS Excel, MS Power Point, MS Access, MS

Outlook, Lotus Notes

. Languages: Spanish Basic - Familiar

MEMBERSHIPS AND AFFILIATIONS:

. Safety Committee- Wuxi AppTec, Inc.

. The National Dean's List: 2003 and 2004

Contact this candidate