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Kimberly Colon Delgado

@kimberlycolondelgado

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I strengthen sterility assurance and microbiological controls across radiopharmaceutical manufacturing.

United States

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What I'm looking for

I'm looking to grow within a company where I can apply my sterility assurance, microbiology, quality systems, and leadership experience to strengthen aseptic operations, contamination control, and regulatory compliance.

At SOFIE, I provide sterility assurance and quality oversight across the radiopharmaceutical manufacturing network. I audit and train aseptic operators, oversee ISO 5 and ISO 7 operations, and review environmental monitoring trends.

I investigate sterility failures, media fill failures, and environmental monitoring excursions using root cause analysis, then develop CAPAs and process improvements. I also write and approve SOPs, protocols, specifications, and technical reports while supporting inspection readiness and cGMP compliance.

Previously at Cardinal Health, I performed microbial limits testing, sterility assurance operations, quality investigations, assay validation, and personnel training. My background also includes pathogen testing at Invisible Sentinel, drinking-water organic extraction at Pace Analytical, and laboratory support in academic and quality-control settings.

Experience

Work history, roles, and key accomplishments

Current

Sr. Sterility Assurance Officer

Current

SOFIE Co.

Sep 2024 - Present (2 years)

Provides sterility assurance and quality oversight across the radiopharmaceutical manufacturing network, including auditing aseptic operators and investigating microbiological events. Develops and delivers training and ensures compliance with cGMP and FDA regulations.

Sterility Assurance Quality Operations Aseptic Technique Gowning Cleanroom Etiquette Contamination Control Environmental Monitoring Root Cause Analysis CAPA SOP流程设计 GMP FDA Regulation USP Training Cross Functional Collaboration

Quality Control Associate I

Cardinal Health, Inc.

Aug 2020 - Apr 2021 (8 months)

Investigated failures of finished and in-process products, prepared reagents and volumetric solutions, and assessed test results against specifications. Ensured compliance with GLP and GMP, supported CAPAs, and reviewed instrument calibrations.

Quality Control Out Of Specification (OOS) Investigations CAPA GLP GMP Reagents Preparation Standardization SOP流程设计 Calibration Pharmacopoeias

Organic Extraction Laboratory Technician

Pace Analytical

Feb 2020 - Aug 2020 (6 months)

Performed organic extraction in the Drinking Water Department, prepared reagents and standards, and maintained logbooks. Followed SOPs and ensured laboratory cleanliness and safety.

Organic Extraction Sample Preparation Reagents Preparation Log Book Maintenance Laboratory Safety PPEs LIMS Excel

Laboratory Technician / Quality Control

Invisible Sentinel a Biomerieux Company

Nov 2018 - Feb 2020 (1 year 3 months)

Analyzed pathogen samples and executed laboratory testing, including creating master mixes for food and beverage testing. Verified equipment calibration and maintained documentation for quality control.

Pathogen Identification Laboratory Testing Master Mix Preparation Equipment Calibration Documentation Quality Control Microscopy Salmonella Listeria E. Coli

Biology Lab Assistant

Interamerican University

Sep 2017 - Dec 2017 (3 months)

Prepared laboratory areas for experiments and ensured instruments were complete and in good condition. Utilized lab skills including DNA extraction, PCR, and volumetric equipment.

DNA Extraction PCR Volumetric Lab Equipment PH Measurement Laboratory Safety Pipetting Beaker

QC Assistant

Saybolt LP

Jun 2016 - Aug 2016 (2 months)

Provided support to quality managers by completing tasks, tracking customer feedback, and assisting with quality control policy implementation. Ran non-destructive tests and tested samples in the lab.

Quality Control Customer Feedback Non Destructive Testing Sample Analysis Petrochemical Laboratory Support