Open to opportunities

Aine Elliott

@aineelliott

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Quality Associate with 10 years of pharmaceutical industry experience.

Ireland

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What I'm looking for

I am looking for a role that values quality and compliance, offers opportunities for growth, and allows me to contribute to impactful projects.

I am a Quality Associate with a decade of experience in the pharmaceutical industry, specializing in managing quality systems and ensuring compliance with GMP, ICH, and regulatory expectations. My career has been marked by a proven ability to collaborate effectively with Contract Development and Manufacturing Organizations (CDMOs), lead quality assurance oversight activities, and drive continuous improvement processes.

Throughout my career, I have successfully executed compliance events, managed change controls, and supported regulatory submissions, including IMPD, IND, and BLA. My role as a sub-team lead for PAI readiness has allowed me to implement innovative processes for stability data management, enhancing the efficiency of quality control operations. I am passionate about fostering a culture of quality and compliance, and I thrive in environments that challenge me to optimize processes and deliver results.

Experience

Work history, roles, and key accomplishments

Current

Quality Associate (Consultant)

Current

Prothena Biosciences

Nov 2023 - Present (1 year 10 months)

Reviewed CDMO technical reports and Module 3 sections to support regulatory submissions including IMPD, IND and BLA. Implemented a hybrid process for stability data management, including oversight procedures, data trending, and transfer to SLIMStat analysis platform.

Regulatory Submissions Stability Data Management PAI Readiness

Senior Compliance Analyst

Norbrook Laboratories

Aug 2020 - Present (5 years 1 month)

Executed and ensured timely closure of compliance events, including deviations, CAPAs, and change controls. Managed the quarantine and rejection processes for raw material inventory in accordance with quality standards.

Deviation Management CAPA Change Control KPIs GMP Documentation

Senior Quality Control Analyst

Pfizer

Sep 2018 - Present (7 years)

Performed cell-based potency assays on drug substances, drug products and in-process samples to evaluate biological activity. Investigated out-of-specification (OOS) and out-of-trend (OOT) results, performing root cause analysis and CAPA implementation.

Cell Based Assays Root Cause Analysis CAPA

Senior Quality Control Analyst

Pfizer

Jul 2017 - Present (8 years 2 months)

Conducted daily routine and non-routine PCR/ Mycoplasma and Virology testing in compliance with GMP regulations. Collaborated with cross functional teams to support instrument validation.

Mycoplasma Testing Virology Testing Continuous Improvement

Quality Control Analyst

Pfizer

Jul 2013 - Present (12 years 2 months)

Performed PCR-based assays for the detection of mycoplasma and viral contaminants on biologic products. Operated and maintained lab equipment including Real-Time PCR system, CO₂ incubators, and biosafety cabinets.

Mycoplasma Detection Viral Contaminant Detection