Open to opportunities

Mallory Muir

@mallorymuir

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Detail-driven Quality Professional with over 12 years of experience.

United States

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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 fosters a collaborative environment.

I am a quality professional with over 12 years of experience in the regulated industries of pharmaceuticals, medical devices, and SaaS. My analytical chemistry background fuels my passion for identifying root causes of issues and implementing improvements to enhance overall quality. I thrive in environments where compliance with standards and regulations is paramount.

Currently, I serve as a Quality Auditor at YPrime LLC, where I develop and execute the quality internal audit program. My role involves performing Computer System Validation and Quality Management System audits, coordinating audit schedules, and addressing risk areas identified during audits. I have a proven track record of preparing for sponsor audits and regulatory inspections, ensuring that corrective actions are effectively tracked and reported.

Previously, I worked as a Quality Compliance Auditor at Medable Inc, where I prepared and executed internal audit schedules and documented nonconformances. My experience includes performing quality audits of software development life cycles and supporting client audits. I am committed to continuous improvement and have successfully implemented process enhancements to ensure compliance and efficiency in quality assurance practices.

Experience

Work history, roles, and key accomplishments

Current

Quality Auditor

Current

YPrime LLC

Feb 2023 - Present (2 years 3 months)

As a Quality Auditor, I developed and executed the internal audit program to ensure compliance with company procedures and regulations. I performed Computer System Validation and Quality Management System audits for eCOA and IRT systems, coordinated audit schedules, and contributed to regulatory inspection preparations.

Auditing Quality Management Systems Regulatory Compliance Risk Assessment Team Coordination Audit Reporting Continuous Improvement

Quality Compliance Auditor

Medable Inc

Feb 2022 - Dec 2022 (10 months)

In my role as a Quality Compliance Auditor, I prepared and executed the annual Internal Audit Schedule, performed audits of SDLC departments, documented nonconformances, and ensured compliance with various standards. I also supported client audits and conducted vendor assessments.

Internal Auditing Compliance Vendor Assessment Process Improvement Risk Assessment Quality Management Systems Audit Reporting

QA Data Reviewer

Akorn Pharmaceuticals

Mar 2017 - Feb 2022 (4 years 11 months)

As a QA Data Reviewer, I reviewed quality analytical services and validation reports for new products. I ensured data integrity and compliance with industry guidelines, managed quality events, and collaborated with various departments to implement improvements.

Quality Assurance Regulatory Compliance Quality Control Team Collaboration Problem Solving Technical Writing

Technical Transfer Analyst

Akorn Pharmaceuticals

Dec 2016 - Mar 2017 (3 months)

In my position as a Technical Transfer Analyst, I performed method validation and verification testing, wrote protocols and reports, and trained end users on laboratory software systems. I also researched new validation methods to align with R&D.

Technical Writing Training Quality Assurance Research Team Collaboration

QC Chemist

Akorn Pharmaceuticals

Apr 2012 - Dec 2016 (4 years 8 months)

As a QC Chemist, I performed analytical testing on raw materials and finished products, ensuring compliance with quality standards. I collaborated with team members to meet deadlines and conducted various physical tests.