Project and Product Manager, Compliance SME

Rate, USD
$90 / hour
Work schedule
Language skills
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About me

Quality Compliance professional with experience in Quality Audits, Product Project Management, CMC document review, and Quality Risk Management. Also, experienced in management of non-conformance compliance, audit procedures, instituting permanent inspection readiness, and project management. Consultant for aseptic processing, engineering process improvements, and quality planning. Risk-based quality practices that are aligned with regulatory requirements and internal quality standards. Focused on meeting compliance objectives and client needs.

Professional area


2021/2022 Master of Science @ University of California San Diego

Biotechnology: Drug Development and Product Management

2019/2021 Bachelor of Science @ MiraCosta College

Biotechnology Manufacturing

2015-2017 Associates of Science @ San Diego City College

Associates in Biology


2022/Current Sr. QA/RA Compliance Specialist @ BioSaRCS Corp

Consultant to CDMOs on Compliance, QA and RA needs. Lead projects based on company needs. Biotech manufacturing, vaccine manufacturing, and medical device companies.

2021/2022 Sr. Compliance Lead @ Cue Health Inc

Lead of compliance department. Reduced turn around times for product disposition and client complaint compliance.

2016/2021 Compliance Specialist @ MilliporeSigma

Tech Ops compliance specialist. Deviation investigations technical writer and CAPA management, process improvement lead, and change control management.

2014/2016 QA Specialist @ Alere Inc

CAPA and change control specialist. Technical writer for procedure improvements for Quality Control, Product Development and Manufacturing.

2013/2014 Lab Technician @ Verenium

Lab technician, procurement management, maintenance of automated equipment, maintenance of bio-library.

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