Assurea LLC

Assurea is on a mission to build the foundation for fast growing companies. We have a unique consulting model that is collaborative and innovative. We always bring the ' A' team to any project. Our services include Quality Compliance, Emerging Technologies, CSV and IT Governance. We believe in solving the current challenges while building a sustainable model for our clients as they scale up.

Co-Founder

ISPE

GAMP America's Steering Committee Member

Steering Committee

Global Compliance Partners

Principal Consultant

CHD Investments

Site Head 

ADVENT Engineering Services, Inc.

Validation Lead

Azzur Group

Engineer II

Hyde Engineering

•	Executed P&ID and Isometric/Construction drawing walkdowns 
•	Review of Turn Over Package, Vendor Documentation, Material Test Reports, and post construction tests ( Pressure, Cleaning and Passivation, Flushing, Process Assessment)
•	Coordination of activities/ execution within client sectors for completion of IQ/ OQ tasks. 
•	In House inspection of process and non process equipment for manufacturing 
•	Documented and Tracked equipment associated vendor documentation

Process Engineer

Pharmatech Associates

•	Executed 13 Facility Qualifications for new suite constructed at an oral solid dosage manufacturing facility
•	Documented facility drawings, air balance report and safety reports in the protocol
•	Used internal software to document material of construction and fill finish of each room
•	Proficient on the use of Logtag temperature sensors used for validation temperature mapping studies
•	Assisted in the development of validation protocols and revision of SOPs for temperature mapping projects
•	Assisted in the Change Control activities for validating a new GMP warehouse facility

Associate Engineer

Amgen

•	Cross functional planning of resources, projects, and maintenance activities during
•	manufacturing shutdown 
•	Alignment of project schedules and cost estimates with input from cross functional capital 
•	project teams 
•	Facilitate in the development of business case, project charter, and project execution tools 
•	Organization of site matrix within SharePoint 
•	Development of project management competency model

Project Management Intern

• Reviewing and transferring equipment risk assessments into the company Software (ORMS) to provide a basic technical library.
• Putting this information onto a web site
• Identifying associated user requirements and providing a technical commentary to them, incorporating them into the web site.
• To review the Quality document hierarchy for Validation and critique it to develop an improved structure that will help simplify the structure of the supporting site Standard Operating Procedures.

Corporate Quality Assurance- Intern

Building Assurea with expertise in Computer Software Assurance  and Quality Management Systems, in particular navigating regulatory compliance with emerging tech and and decentralized systems. 

I'm passionate about my work with our RootingForYou campaign and providing a platform for women and underrepresented groups to celebrate their accomplishments, self promote and have a supporting network that is rooting for them!

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