Karmen Martinez James Phone: 210-***-**** email: ad0nvm@r.postjobfree.com

Objective: Results-driven and detail-oriented quality professional with extensive experience in quality and compliance. Offering a diverse background in regulatory affairs, spanning blood banking and food quality environments. Adept at applying critical thinking skills to recommend and implement effective process solutions. Possesses exceptional service orientation and excels in meticulous document review. Seeking to leverage my expertise to contribute to the success of a forward-thinking organization. Employment History

Biobridge Global, San Antonio, TX

02/2007 – 04/2023

Biomedical Compliance Manager

• Administrator of the Equipment Management, Calibration and Maintenance Software of over 5000 assets with creation of Maintenance Routines and Maintenance Rules IAW equipment manual Calibration & Maintenance interval requirements

• Administrator of the REES System Temperature and Alarm System of 450+ monitoring inputs Administer probe set up and user access and permissions and assured completion and verification for 450 probes.

• Responsible for developing and overseeing many biomedical operational activities, NIST Traceable equipment calibration, asset service status oversight with release process.

• Assisted QA in gathering equipment calibration and maintenance documentation for over 20 regulatory and customer audits per year (FDA, ISO, CLIA, EU, cGMP, ISO, OSHA)

• Evaluated all cold storage and incubator required maintenance and calibration records.

• Performed the analysis of 37 Walk-in Cold Storage units for Annual Mapping and QA release.

• Initiated equipment deviations, risk assessments and SOP revision using Master Control

• Assisted in cold storage and incubator new asset validations.

• Responsible to revise Equipment Standard Operating Procedures using Master Control

• Assigned as a safety warden responsible for ensuring the safe exiting of personnel during fires/fire drills and general safety.

• Experience with biohazardous waste handling.

Surlean Foods-Meat Company

04/2002 – 09/2006

Quality Assurance Supervisor

• Supervised and monitored testing processes in both food chemistry and microbiological analysis of meat and meat products.

• General familiarity with Hazard Analysis Critical Control Points.

• Experience in the review of QC/QA production records for completeness, correctness and compliance.

• Supervised five laboratory staff personnel in a food chemistry and microbial laboratory.

• Responsible for ordering and maintaining both chemical and microbial reagents and supplies.

• Researched and recommended for better and continuous improvement processes and equipment.

• Participated in microbial proficiency testing.

• Solely responsible introducing and attaining 3M Petrifilm with replacement of the standard plates for microbial testing and introducing the IDEXX swabbing system for real-time sanitation microbial count results.

• Chemical percent fat and moisture analysis testing experience using rapid method CEM food fat extractor instrumentation.

• Microbial experience testing for 0157:H7 presumptive testing, Aerobic Plate Count, Listeria monocytogenes and Staphylococcus and Clostridium Perfringens testing in accordance with BAM Methodology. Experience in making microbial broths.

• Autoclaving experience and autoclave maintenance interval requirements with vendor.

• Participated in FDA audits and sample shipments. Methodist Hospital 1999-2002

San Antonio, Texas

Phlebotomist

• Performed venipunctures for both adult and neonatal patients.

• Performed venipunctures using butterfly and syringe procedure on arm.

• Performed PKU testing on newborn babies.

• Performed Bleeding Time testing.

• Performed in performing Glucose tolerance testing. Education History

08/1990: BS Science - Biology

University of Texas in San Antonio, San Antonio, TX Occupational Licenses, Certificates and Training:

09/2021 Green Belt Certification: Martin Landon, Chief Executive Officer 03/2018 Yellow Belt Certification – Six Sigma Global Institute 08/2011 Certificate of Recognition in Excellence – Issued by Qualtex Labor Community Activity

Volunteer of the "Camp Discovery" team at BioBridge Global from 2018 to 2023. Raised funds to provide summer camp experience for children with cancer.

References:

Charles Wilkins, Assistant Director

BioBridge Global

p: Charles ad0nvm@r.postjobfree.com

e: 210-***-****

Karen Leighton, Development Manager R&D

BioBridge Global

p: ad0nvm@r.postjobfree.com

e: 210-***-****

Vanessa Padilla, Compliance Manager,

Confirmatory Testing Reference Laboratory

Biobridge Global/ University Hospital Laboratory Supervisor p: 210-***-****

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