Morgan Walsh

Provided on-site QA oversight for clinical manufacturing operations, including batch record review/compilation, media/buffer and raw material disposition, and validation support.

Executed QA review and approval of GMP documentation (batch records, Change Controls, Deviations, CAPAs, SOPs, and specifications).

Managed Quality Systems, including ownership of Change Controls, CAPAs, and Deviation investigations.

Developed, tracked, and analyzed Quality metrics to identify trends and drive continuous improvement.

Supported regulatory inspections, internal audits, and product launch readiness initiatives.

Authored and revised SOPs, specifications, and work instructions to align with compliance standards.

Served as Quality Assurance reviewer for contract manufacturing of nucleic acid API, ensuring compliance with cGMP standards under FDA CFR Title 21.

Collaborated with Manufacturing, Document Control, and Quality Control to enhance raw material supply and in-process quality.

Reviewed batch records and cleaning forms directly on manufacturing floor for accuracy and compliance.

Guided Manufacturing team on actions during potential non-conformance situations to ensure quality.

Assessed process equipment and GMP facility work orders completed by Calibration and Process Maintenance departments.

Compiled reports for Non-Conformance Records, Change Controls, and laboratory investigations for client documentation.

Examined raw material documentation and approved materials for release to Material Management.

Utilized SAP to organize batch records and Quality Control results for final API product disposition.

Contributed to deviation saves list, resulting in $10,000 savings on major deviations and $7,500 on minor deviations.

Supported Antigen and FFIP departments during Covid-19 pandemic response.

Provided quality audit expertise for cross-functional FDA inspection readiness of new Influenza building.

Assisted in formulation scale implementation project, ensuring smooth transitions.

Oversaw removal of WFI sampling site in preparation for 2021 shutdown, encompassing upstream release valve impacts.

Collaborated on FFIP Maintenance Shop Renovation Project to enhance operational efficiency.

Completed redlining for site-wide Traffic and Gowning document to ensure compliance.

Finalized redlining for Quality Assurance Area Release Requirement Forms to meet regulatory standards.

Led water sampling team to fulfill minimum requirements for all water systems in Building 59.

Implemented autoclaves throughout the building to ensure equipment sterility prior to use.

Delivered expert guidance to management, meeting processing deadlines and quality standards.

Overcame challenges in developing and implementing environmental monitoring program for over 10 employees.

Evaluated environmental integrity of building and personnel to enhance product quality and sterility.

Increased productivity and reduced manufacturing deviations by 50% in March 2019.

Streamlined production processes for weighing, measuring, and dispensing buffer filtration.

Maintained aseptic gowning qualification while ensuring compliance with cGMP, CBER, WHO, and EP regulations.

• Recognized by senior management for outstanding performance and promoted to lead technician position.