Robbie Rawls AA BS

Microbiologist, Laboratory, Quality, Pharmaceutical, Medical Devices

Cell phone: 310-***-****

Email: acxnib@r.postjobfree.com

Torrance, CA 90503

Summary

I am seeking employment with in a company that allows many challenges for someone in the microbiology field. I am skilled in various microbiology and some chemical testing. I have been the Subject Material Expert when it comes to testing using aseptic techniques when it comes to testing like sterility, endotoxin, bioburden and environmental testing as well as validate cleanrooms and devices. I am seeking more knowledge and stability as well as growth to thrive within a company that is committed to changing the lives of their patients.

Education

Venice High School: Diploma 1981

El Camino College: AA Degree in General Studies 2001 California State University Dominguez Hills: BS Degree in Community Health 2007 Experience

Edwards Lifesciences Irvine, CA !/2006 to

12/2014

Baxter Los Angeles, CA 05/2006 to

09/2006

Harbor UCLA BioMed Research Torrance, CA 12/2004 to 01/2006

Physician's Formula Ontario, CA 10/2003 to

02/2004

BioScreen Testing Services Torrance, CA 05/2000 to 12/2004

Certification

Computer Science 05/1986

Medical Terminology 05/1993

Protecting Study Volunteers in Research 01/2005

Protecting Health Information (PHI) 01/2005

Summary of Experience

Since 2000 I have picked up skills to add to my resume starting with Setting up monthly meetings to ensure that testing and environmental testing will not be compromised. Review the chain of custody to ensure the right number of sample were sent and the paperwork is complete then move the sample forward. Microbiology Testing, Quality Assurance / Quality Control is an everyday task that needs to be released in the morning along with environmental results. Ensure the cleanrooms, personnel coming and leaving along with the water system are in compliance, if there is an Out Of Specification (OOS) or 3 (OOS) within 1 year, I would retest and revalidate if needed, I can release using the results from Endotoxin (LAL) testing I test for viable and nonviable air samples. I have had to validate Sterilization chambers including the steam process at 250 C.I have had to check SOP's/ ISO/ USP's / AAMI so that I can answer questions about knowing whom ever did the testing knows the method being used, with that I still pull up my check-list to beware if the personnel has been trained on that method. There are a few SOP's / ISO methods being looked at before testing starts. ISO 9001 (Quality), ISO 14001 (Environmental Quality), ISO13485 (Certificate for Medical Devices) ISO14160 (Validate Liquid Sterilization). There are a number of ways to validate devices they are Ethylene Oxide Gas (EO), Electron Beam Sterilization (E- Beam), Gamma Liquid Sterilization . Steam Sterilizer are usually monitored by using a printout, measuring temperatures at certain times, at certain sites. Sterility Assurance Level (SAL) is the estimate of the lethality of the entire sterilization load with the calculation 10-6. I also have performed Installation, Operational and Performance

(IQ, OQ,PQ). My Microscope techniques and inoculation if devices are very strong. Computer Skills:

Proficient in Microsoft Excel, Microsoft Word, PowerPoint and LIMS References:

Edwards Lifesciences Supervisor – Kingsley Derby 949-***-**** acxnib@r.postjobfree.com

Harbor UCLA BioMed Supervisor Andrew Leung 310-***-**** acxnib@r.postjobfree.com

Baxter / Kelly Services Supervisor Nyree Krikorian 818-***-**** No e-mail that I know of

My Duties are as Follow:

Develop, revise and review SOP's, CAPA, OOS and Protocols Open investigation for OOS

Support team member's

Monitor the laboratory for media and pull equipment for calibration Monitor and trend data

Interact with internal and external for Audit's

Maintain Compliance to regulations and Standards

Set-up training for all as well as new hiring

Perform qualitative and quantitative analysis

Perform challenge plating

B and F testing

Perform quarterly testing on company devices

I have maintained organism used for testing

Generate CoA for release

Growth Support for all media in the laboratory

Preparation of sample being sent for dosing

Preparation of standards and controls

Endotoxin (LAL) testing

Bioburden testing

Sterility Testing

ID organisms using Vitek at times

Contact this candidate