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Brooke Smith

@brookesmith

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Quality Control Operations Supervisor with expertise in microbiology.

United States

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What I'm looking for

I seek a role that fosters professional growth and values quality assurance in pharmaceuticals.

As a Quality Control Operations Supervisor at Adaptimmune, I have honed my skills in contamination control strategy and quality assurance within the pharmaceutical industry. My role involves overseeing the QC Microbiology Department, where I manage multiple direct reports and ensure compliance with cGMP and regulatory requirements. I am proficient in various quality control systems and methodologies, including MODA, LIMS, and MasterControl, which allows me to effectively monitor and test products to meet technical standards.

Previously, I served as a Quality Control Microbiologist Analyst II at Endo Pharmaceuticals, where I led investigations into microbiological product results and trained new analysts on critical testing methods. My experience includes performing microbiological testing, environmental monitoring, and maintaining compliance with industry standards. I am passionate about continuous improvement and have successfully implemented CAPAs and quality protocols to enhance operational efficiency.

Experience

Work history, roles, and key accomplishments

Quality Control Operations Supervisor

Adaptimmune

Apr 2023 - Present (2 years 3 months)

As a Quality Control Operations Supervisor, I am the SME/Collaborator on the Contamination Control Strategy for the Company. I perform reviews and approvals on all DEVs, CAPAs, Change Controls and Risk Assessments for Manufacturing and Quality Control Operations Departments.

LIMS MasterControl Lab Testing Quality Control Risk Assessment

Quality Control Microbiologist Analyst II

Endo Pharmaceuticals

Oct 2019 - Present (5 years 9 months)

As a Quality Control Microbiologist Analyst II, I participated in the investigation of microbiological product OOS results and DEV as needed using TrackWise Digital. I identified root cause using tools such as fishbone diagrams and five why’s and implemented CAPAs as required.

Trackwise SOPs Technical Documentation Quality Control Training Root Cause Analysis CAPA

Filling Technician

Fujirebio Diagnostics

Jun 2018 - Present (7 years 1 month)

As an Aseptic Filling Technician, I produced pharmaceutical products in sterile clean rooms. I set up clean rooms, followed proper aseptic procedures, and operated/maintained manufacturing machinery and equipment to complete each filled pharmaceutical product.

Aseptic Filling Products Quality Control

Education

Degrees, certifications, and relevant coursework

Widener University

Bachelor of Science, Biology

Activities and societies: Highlighted Coursework/ Lab Skills: General Chemistry I and II with Labs, Organic Chemistry I and II with Labs, Genetics with Lab, Microbiology I and II with Labs, PCR, DNA/Extraction/Quantification, Spectrophotometry, Computer Data Analysis, Microscopy, Genetics.

Completed a Bachelor of Science in Biology, gaining a strong foundation in scientific principles. Coursework included General Chemistry, Organic Chemistry, Genetics, and Microbiology, all with corresponding lab components. Developed practical lab skills such as PCR, DNA extraction and quantification, spectrophotometry, and microscopy.