Rashida M. Noel

**** ******* *** ** ********, GA 30152 Cell: 770-***-**** aca40u@r.postjobfree.com

Profile

* ***** ** *********** ********** implementing food, medical device, and pharmaceutical

regulatory compliance

Managed 4 departments (Purchasing, Reporting, Warehouse, and Laboratory Support)

consisting of 20 employees.

Excellent Project Management skills with commended performance analyzing laboratory

assays and resolving complex test results to ensure compliance with ISO / AAMI / 21CFR /

EP standards

Education

MBA, General Management & Marketing – 2008

Kennesaw State University – Coles College of Business,

Kennesaw, GA

BS, Biology, Minor in Chemistry – 2004

Oneonta State University – SUNY, Oneonta, NY

Key Performance Areas

Regulatory Technical Expertise

• Managed the process of designing and launching global, complex clinical research studies. Lead activities involving the Sponsor/Clinical

Research Organization (CRO), while guiding the Project Manager and Set up Coordinators in designing project components. Developed the

database design requirements which included configuration (project specific kit contents, laboratory events, requisitions and medical

reports) and programming for full protocols. Prepared and presented study specific materials at Investigator, Kick off and Bid Defense

meetings. Provided additional training to the sponsor, CRO, and site personnel as required in addition to mentoring internal junior staff.

• Evaluated client medical device and biologic samples to determine the required laboratory testing needed to meet FDA guidelines

prior to their market entry. Wrote client protocols referencing applicable standards and developed product specific testing procedures for

Bioburden, Sterility and Bacterial Endotoxin. Calculated radiation sterilization doses and coordinated all internal and contracted testing,

presenting results in a final report utilized by clients as a FDA deliverable. Held the role of Project Manager for 38 products from 28 different

clients, and acted as a consultant for numerous others.

Laboratory and Lean Management

• Experience in a GMP / GLP laboratory setting utilizing aseptic techniques and clean room gowning procedures. Trained personnel on

proper methods of sample handling, preparation, testing and subsequent review / interpretation of all data before the results are reported to

client. Responsible for tracking and trending Lean metrics for Reporting & Support Services, while collaborating with laboratory

managers to improve Lean Metrics. Responsible for invoicing and reporting monthly revenue to the corporate office.

Business Process Improvement

• Streamlined the sample login and worksheet generation process which entailed combining 3 departments into one cohesive unit,

cross training 7 employees on 8 different job functions, workflow adjustments, and development of new SOPs to solidify the operational

improvement. Reengineering included staff training, quality control, conflict resolution, process documentation, and performance review

process.

Employment History

Quintiles, Project Set Up Manager, 2013 Present

WuXi AppTec, Inc. (formerly AppTec Laboratory Services)

Reporting and Laboratory Support Manager, 2010 – 2013

Project Manager, 2008 2010

Cobb and Douglas Public Health, Health Inspector 2007 – 2008

New York City Department of Health and Mental Hygiene, Environmental Health Specialist 2005 – 2007

Computer Skills

MS Office (Word, Excel, Outlook, PowerPoint), StarLIMS, SPSS, Lotus Notes

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