Jamie Moore Email & Phone Number

New York, NY, US

Durham, North Carolina, US

Waltham, MA, US

• Drive data integrity and digital quality projects across global VVS sites, provide quality oversight for data integrity related issues
• Execute and project manage VVS data integrity plans, strategies, and objectives
• Provide QA oversight in leading data integrity risk assessments, investigations, change controls, CAPA, internal/external audit support, and CSV lifecycle activities
• Lead departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity for both paper/electronic records, and good documentation practices
• Lead data integrity surveillance/gemba activities across VVS to promote DI awareness and improve Quality culture

Morrisville, North Carolina, US

• Developed VMP/QC Lab qualification strategy for a newly constructed Gene Therapy facility
• Developed site Validation SOP for Analytical Assets
• Manage and lead team for development/execution of qualification protocols for various laboratory and manufacturing instruments/equipment
• Manage and report overall project finances, resource plans, and deliverable completion, reporting directly to the Sr. Director of QC

Morrisville, North Carolina, US

• Responsible for coordinating all activities related to Environmental Qualification (EQ) of a retrofit gene therapy Grade A (ISO 4.8/5), Grade C (ISO 7), and Grade D (ISO 8) classified manufacturing clean space
• Actively managed internal/contract resources associated with executing test plans, including site selection risk assessments, investigations of action/alert levels, and provided justification for site CAPAs and.
• Served as technical project lead on behalf of QC for managing PQ related sampling/testing activities required for qualifying and routinely maintaining a newly constructed WFI generation and clean steam system
• Developed and executed qualification protocols for facilities, utilities, and equipment
• Interfaced with operational readiness managers and various departments to facilitate completion of required deliverables on schedule
• Managed and reported weekly on overall project finances, resource plans, and deliverable completion

Morrisville, North Carolina, US

Led a multi-phased project focused on developing a previously research-oriented lab into cGMP compliance associated with AIV. This included compliance and data integrity gap assessments and implementing qualification procedures for instruments/equipment based on USP <1058> and GAMP 5 among other regulatory guidelines.-Development of overall site AIV SOPs.

Morrisville, North Carolina, US

Responsible for leading periodic review assessments for QC and Stability departments instruments/equipment also including authoring validation protocols for temperature mapping of controlled temperature units.-Identified compliance gaps against current/missing qualification procedures and prioritized remediation of systems based on criticality of assets..

Morrisville, North Carolina, US

• Responsible for supporting QC laboratory management in the oversight of key functional, tactical, and operational aspects of the QC Laboratory Operations group at the client's Cambridge facility. This oversight.
• Data Integrity Assessments
• Authoring technical documents/protocols
• Scheduling, and balancing of workload with respect to instrument availability
• Prioritization of projects
• Adherence to regulatory licenses, regulations, and guidelines (i.e. USP <1058>, 21 CFR Part 11, and EU GMP Annex 15)

Morrisville, North Carolina, US

• Provide nationwide deployment and monitoring services for installation/calibration of over 1000 controlled temperature units (CTU)
• Responsible for assistance with hardware connectivity and installation operational verification (IOV) technical support
• Create change management documentation for CTU monitoring services
• Development/writing of company SOP's
• Perform upgrade assessments for analytical hardware/software instruments in virology, chemistry, and bioassay laboratories
• Communicate with many laboratory instrument vendors to identify PC/Software/Firmware upgrade requirements

Provided lab assistance/research in the pulmonary physiology department. Specifically, focused on culturing C10 strain mice lung epithelial cells and exposing them to different doses of Venadium Pentoxide (V2O5). Results were evaluated using several techniques such as centrifuge, PCR, nanodrop, as well as producing cDNA, RNA, and mRNA.Other projects.

Bachelor Of Science (Bs), Biomedical/Medical Engineering

Education record