Quality professional position performing Document Control Edits to divisional documents, procedures, and Processes.• Authoring change packages in APLM for new documents and revisions to exiting documents.• Assisted leading CFTs in the Design Planning System. Design Planning Change Process.• Perform edits to documents consistently using OP’s and processes to maintain the compliance of the quality system.• Identifies priorities and can rearrange workflow to support audits, audit readiness and customer needs.• Strong organization skills to maintain the scheduling requirements that will not delay new product launches, quality enhancements, corrective and preventative actions or cost reductions.

Implementation of validation, relocation, and calibration of engineering and development equipment. Collaborated with cross-functional team members to determine the validation requirements, execute equipment validations, and complete associated documentation. Assisted with commissioning equipment and set up of documentation/system packages for new equipment. Helped create and review equipment protocols, reports, and work instructions.

Execute protocols to analyze assay integration and instrument functionality on developing in-vitro diagnostic instruments. Performed IQ/OQ and Test Method Validation testing on developing instruments. Conducted validation protocols supporting instrument product development from an engineering prototype to a manufacturing prototype. Interpret and execute protocols to verify Clinical Chemistry and Immunoassay instruments while adhering to GLP, GMP, and SOPs. Qualified as a Subject Matter Expert (SME) to train new hires in executing protocols on Clinical Chemistry and Immunoassay analyzing platforms.  Implement 5S Lab Management Methodology to increase testing throughput, mitigating procedural errors.  Assist in preparing protocols for assay development and instrument troubleshooting investigations.  Witness electronic laboratory notebooks to ensure accuracy and precision. Summarize and clean data to conduct statistical analysis.

ChemistryOrganized specimens for loading onto analyzers. Prepared standardized reagents utilized by the analyzer(s) and performed waived testing. Hematologyset up peripheral smears, reticulocyte counts and sedimentation rates. MicrobiologyPlated bacteriologic culture specimens to appropriate media and prepared gram stains.

Processed all laboratory specimens by receiving, registering and ordering all tests. Assured accurate and proper collection, identification, labeling and specimen integrity. Prepared all samples to be sent out to outsourced laboratories.

Service a patient population of pediatrics, young adults, adults and geriatric patients. Handled microbiology specimens and performed waived testing. Performed special testing procedures that required specimens to be sent to other labs.

Completed 100 clinical hours within the outpatient lab, and inpatient wings.Preformed venipuncture, capillary sticks, and other specimen collection techniques on numerous patients.