Maggie Bari Email & Phone Number

Fargo, North Dakota Area

Author and update the Computer System Validation polices and procedures. Consult on the update to the Master Validation Plan and Software Inventory.

Austin, Texas & San Diego CA

➢ Served as Software Quality Assurance and authored initial validation documentation for SLIM (Stability Lab Information Manager). After project restructuring, led the SLIM validation effort to a successful launch. Served as System Administrator during the validation process.➢ Managed the qualification of the TransPerfect’s Trial Interactive clinical.

Greater San Diego Area

Served as Software Quality Reviewer Team Lead for Diagnostic products, manufacturing equipment and laboratory instruments. Partners with Validation Engineers to ensure compliance to company procedures and Part 11 regulations to ensure new product development. Brought a multi-phase remediation project to closure, ensuring that the manufacturing equipment.

Cincinnati, Ohio Area

Authored comprehensive suite of Software Quality procedures, assessments, and templates. The Software Validation Life Cycle is aligned with GAMP 5 life cycle phases (Concept, Project, Operation, & Retirement). Supporting procedures include Master Validation Plans, Periodic Reviews, and Software Inventory. Specialty procedures include Spreadsheet.

Fort Washington, PA

Computer System Validation Lead ~ Computer System Validation Quality Assurance (Consent Decree)Serving as Delegate representing the Associate Director Computer System Validation Quality Assurance to the consent degree’s computer system validation (CSV) program. Provide counsel and input on both the team and leadership level to the Computer System.

Fort Washington. PA

Developed suite of 17 CSV foundational SOPs; including updating the existing 6 core validation lifecycle SOPs, authored supporting and specialized SOPs. Worked with Associate Director of Computer System Validation Quality Assurance and Quantic mentor to ensure alignment with overall vision and compliance with company standards and health authority.

Quincy, MA

Led the validation effort of the site’s implementation of a robotic warehouse automation system. Developed the validation strategy for the two work streams, authored test plans, provided expert guidance to vendor on the 21 CFR Part 11 design requirements. Created Validation Abstracts for each of the system’s functional areas which contained testing.

Spencer, IN

Managed the Legacy Software Remediation project for the Spencer Indiana site. Lead an international team of twelve assessing and remediating Quality System software and manufacturing systems. Also consulted on 21 CFR Part 11 compliance concerns, change control, and current validation efforts. Authored new and updated existing site SOPs, software testing.

Quincy, MA

Remediated legacy Quality System software; conducted internal software audit; and advised potential vendor on installation of a Quality System. Also consulted on 21 CFR Part 11 compliance issues.

French Valley, CA

Managed the Qualtiy Systems (CAPA and NCR) as this site prepared for closure. Conducted Internal Audits for compliance to 21 CFR Parts 820 and 11, ISO 13485, and Canadian regulations. Managed the implementation of Quality System corrective actions based on internal audit findings. Prepared and presented Quality System information for monthly Management.

Mountain View, CA

Developed and maintained multi-year, three-phase project plan (schedule), the project’s quality plan, and management presentations on the validation remediation of the site quality system and production legacy system. Recruited and interviewed resources for Legacy Remediation project. Facilitated team collaboration on project deliverables. Developed.

Spencer, IN

Managed the Endoscopy CAPA portfolio during the implementation of the upgraded CAPA process. Brought eleven open legacy CAPAs to closure by facilitating the execution of CAPA plan through working with all levels of people, from the Plant Manager to Production Line Operators. These project's goal was to have all open CAPAs within the newly established.

Murrayville, PA

Authored requirements document for new multi-site CAPA management system. Consulted with Senior Corporate personnel on system architecture requirements. Conducted analysis of potential software solutions from a variety of national vendors. Consulted on software assessment forms and company SOPs on software validation in equipment and automated systems..

Natick, MA

Conducted key Supplier audits across the country focusing on software and qualtiy systems. Partnered with Suppliers on resolving NCRs and SCARs. Served as Project Manager on Supplier Contract Review project. Authored project plan. Coordinated team member’s training and work assignments. Sat on Steering Committee that reviewed results and ensured.

Maple Grove, MN

Served as Senior Software Quality Engineer on the development and launch of multi-station automated catheter manufacturing lines. Reviewed, commented, and approved document deliverables for all phases of a robust System Development Life-Cycle (SDLC) as part of a rigorous validation effort.Authored related training and deliverable templates still in use by.

Groton, CT

Doctor Of Business Administration, Finance

Ms Coursework, Accounting

Bachelor Of Science In Business Administration, Accounting