Madison

Perform review of submitted clinical data, database entry, and source document verification in accordance with established SOPs.. Assist the Clinical Trial Manager with site management activities, including review of monitoring reports and source document review.. Reconcile clinical trial data across EDC, TMF, and CTMS systems to ensure accuracy and consistency of study records.. Support invoicing for clinical trial sites.. Support continuing review submissions with the IRB.

Directed and oversaw the enterprise-wide GxP training program, serving as the primary subject matter expert across all departments and functional areas.. Administered ZenQMS as the company's electronic Quality Management System (eQMS) and Learning Management System (LMS), delivering super user training to system administrators and general user training to employees; managed users and access management, created and maintained training matrices and training plans, and monitored training compliance and data integrity at the individual, departmental, and company-wide level; supported workflow configuration and validation activities for system and template changes, and generated weekly and monthly KPI and compliance metrics for leadership.. Facilitated instructor-led GDP and compliance training for 30+ employees, including onboarding for all new hires and presentations to senior leadership; built quizzes and knowledge checks within ZenQMS to assess training effectiveness, informed by a Train the Trainer certification (Business TrainingWorks).. Managed the complete lifecycle of controlled documents, including formatting, routing, review, approval, issuance, revision, obsolescence, and archival; served as a training compliance SME for quality systems including Change Controls, and led audit and self-inspection readiness efforts - including reconciling paper and digital records such as CVs, Signature Forms, and ZenQMS User Account Forms to ensure data integrity - advising management on compliance trends, risks, and inspection preparedness, including supporting a recent mock FDA GCP audit.. Authored, revised, and streamlined SOPs and job aids in adherence to 21 CFR Parts 11/210/211 and ICH Q10 standards, identifying compliance gaps and reducing approval cycle times by ~75% from an average of 24 calendar days to 6 calendar days until approval.. Analyzed and presented training metrics to senior leadership, driving initiatives that brought organization-wide GxP compliance completion rates to 90%+ and sustained them; served as sole presenter for the Quality Management Review (ICH Q10), delivering training, document status/lifecycle, and CAPA/deviation data directly to senior leadership.. Managed document and system support requests through internal ticketing platforms (NetworxGrid IT service desk, ZenQMS support queue), prioritizing and resolving requests from cross-functional teams in a timely manner.. Partnered with Clinical Operations, Clinical Research, CMC/Technical Operations, and non-GxP groups to align training and documentation requirements with day-to-day quality assurance operations.. Supported Regulatory Affairs with regulatory submission uploads in RIMS and participated in a vendor audit for the Clinical department, ensuring documentation accuracy and GxP compliance standards were met.. Supported the conversion of an existing Research laboratory to GMP-compliant operations, authoring and reviewing SOPs to establish quality systems infrastructure, including environmental controls readiness.

Facilitated company-wide GxP compliance training programs, including GDP and new hire onboarding, for 45+ employees, cultivating a strong culture of quality and regulatory adherence.. Drove implementation and optimization of ZenQMS, the company's Quality Management System, overseeing seamless rollout of training and documentation modules across 10 departments.. Owned the full lifecycle of SOPs and quality documentation, reviewing, revising, and maintaining records, to ensure ongoing accuracy and GMP/GCP regulatory compliance.. Identified quality system gaps in partnership with QA colleagues and led closure through CAPAs and continuous improvement initiatives, reducing open deviations by ~30%.. Served as the primary resource for training and QA inquiries, advising stakeholders on compliance best practices and audit readiness expectations.. Collaborated with Regulatory Affairs to support submission uploads into RIMS, gaining hands-on experience with regulatory documentation workflows and submission lifecycle management.. Provided QC backup support for pathology slide review for an active Phase 3 clinical trial, collaborating with the Clinical Operations team to ensure GCP-compliant data quality oversight.

Provided QA oversight of manufacturing batch records for a contract development and manufacturing organization (CDMO), and prepared and issued controlled logbooks and laboratory notebooks, ensuring accuracy and GDP compliance across 50+ batch reviews.. Reviewed and coordinated calibration and preventive maintenance records with Facilities and QC using Blue Mountain RAM, helping ensure equipment remained compliant with applicable requirements.. Supported QC operations by reviewing in-house and outsourced analytical testing data, contributing to material disposition decisions.. Served as backroom support during third-party external audits and coordinated preparation, packaging, and shipment of controlled documents to Iron Mountain for off-site archival, supporting document retention procedures and audit readiness.. Supported document management and review within Veeva Vault QMS, and assisted with testing scripts for the Deviation/Nonconformance module during system validation (computerized system validation/CSV).

Executed aseptic cell culture, differentiation, and handling techniques within GMP cleanroom environments.. Authored GMP batch records and collaborated with the Process Development team to facilitate tech transfer to GMP operations, ensuring accurate documentation and training.

Operated in ISO/FDA-regulated cleanrooms; authored and reviewed SOPs; managed reagent inventory.

Processed cellular products; cryopreserved/thawed bone marrow and apheresis; utilized MasterControl for controlled document management and Iron Mountain for off-site archival; served as SME for thawing procedures.

Built assays per customer specifications; maintained GMP/ISO documentation; supported LeanKit system implementation.

Revised 600+ client-specific protocols; updated calibration records; edited SOPs within GMP/ISO 17025 compliance.