Immanuel Moss Email & Phone Number

Lexington, Massachusetts, United States

· Quality lead for lab and manufacturing equipment design, qualification, and maintenance/calibration, ensuring it remains in control.· Support continuous improvement of Data Integrity initiatives through SDLC GAP Assessment and remediation.· Authored and executed UAT/PQ test scripts, ensuring computerized system compliance with 21 CFR Part 11 and EU Annex 11.· Generated Risk Based Assessments to determine the GAMP 5 category of computerized systems.· Support Vendor Audits and Supplier approval processes.· Author and manage resolution and final disposition of all test execution Deviations.· Provided QA oversight of GxP IT System Validations and Strategic leadership of the Data Integrity program.· Oversee the SDLC review and approval for Quality and all CSV (Computer System Validation) activities for GxP systems.· Support the implementation of quality systems learning management software (LMS) and Computer System Validation (CSV) of Lab Instruments.· Facilitate the generation and approval of quality management system (QMS) events (Change Controls, CAPAs, Deviations, and WOs) via Veeva

Cambridge, Massachusetts, United States

· Reviewed Quality Records (Change Controls, CAPAs, & Deviations) via Trackwise.· Performed Requal/Performance Qualifications via Kneat (GxP Validation Software).· Executed IOQs on Incubators, Freezers, Cold Rooms and other CTU’s. · Lead CQV Engineers in the completion of Equipment Qualifications.· Communicated project timeline predictions cross departmentally (Quality, Ops etc.)· Managed various validation projects simultaneously to completion.

Rensselaer County, New York, United States

· Drafted Continuing Validation Assessments through collaborative review.· Performed peer review of GMP Validation Documents.· Reviewed and assessed events (Change Controls) related to CIP/SIP.· Compared Cleaning Recipe SOPs to field data to verify consistency.· Assessed stability of the cleaning cycle by reviewing KPI trending reports.

Lock Haven, Pennsylvania, United States

· Perform weekend drills once a month at the armory· Lead platoon to accomplish tasks given by Cadre as Assistant Platoon Guide· Drilled to be disciplined and very attentive to detail· Trained as Hotel 8 certified 91H – Track Vehicle Repairer & Recovery Specialist· Repaired all systems on vehicles including: Hydraulic, Braking, Steering etc.

Philadelphia, Pennsylvania, United States

· Executed cleaning validations on equipment used in manufacturing of Flu Vaccine· Assisted in the completion of CIP cleaning validation studies for portable tanks· Performed IOQ on Controlled Temperature Units using Kaye Equipment.· Managed multiple validation projects simultaneously to meet deadlines· Participated in Level Zero investigation activities· Worked diligently to build relations with other work streams to a better final product· Functioned as a member of a cohesive team to accomplish validation activities

Greater Philadelphia Area

· Develop and execute tests for new equipment and/or continuous improvement initiatives· Executed IOQ protocols for various Pharmaceutical/Med device companies· Provide technical assistance to clients on various equipment and features.· Calibrating various equipment to client specifications· Confer with management and other staff regarding scheduling and process improvements· Analyze data, summarize and document test results

Dallas/Fort Worth Area

Responsible for creating multi-axis laser programs for service departmentRedlined drawings for future updates per weekly multidisciplinary meetingsGenerated and modified existing work instructions and standard operating proceduresProvided production & validation support from a Manufacturing/R&D perspectiveTasked with implementing EU MDR European initiativeEnsured all processes are GxP compliant per FDA regulations including CFR Part 11

Fort Worth Texas

Responsible for creating/executing IQ, OQ, and PQ documents required for validationInspected all cabinets to ensure proper wiring and communication with PLCCompleted in the field equipment verifications with SCADAWorked as a liaison between outside vendors & Alcon to complete various tasks around siteInspected manufacturing lines for process improvement purposesReviewed all process loops to guarantee sterility throughout the manufacturing processCoordinated the completion of equipment calibrations to remain in good standings

West Point, Pa

Validated all Manufacturing Equipment (including WFI Generation Systems)Created & Executed Process Qualifications on Tanks/Blast Freezers/Liquid Nitrogen TunnelsPerformed/Supervised Maintenance repairs on HVAC & Autoclave equipmentWorked with various outside vendors to accomplish process improvement projectsFunctioned as a liaison between Operations and Maintenance to accomplish set tasksCoordinated the completion of Corrective Maintenance as well as Preventative MaintenanceExperienced with managing union employees as well as contractors

Parsippany, Nj

Global leader in the medical device industry for implantable orthopedics products Responsible for implementing Installation/ Operational/ Performance Qualifications Completed IQ/PQ/OQ on various Multi-Axis Mitsubishi CNC MachinesInvolved for CAPA remediation activities and manufacturing capability analysis Created Standards of Operations (SOPs) and trained technicians to the updated processDesigned fixtures for Multi-Axis CNC’s, Wire EDM machines, and QA inspectionExperience with Engineering Design Change & Approval process