Mackenzie Mcgrath Email & Phone Number

Medford, Ma, Us

Amsterdam, Nl

Contracted to Moderna Capital Projects Group

Amsterdam, Nl

Provided project managment for NPI projects. Maintained trackers, meeting minutes and dashboards for multiple projects. Communicated with SMEs and service providers to ensure timely request and action completion. Built schedules based on requested delivery timelines and communicated changed or delays appropriately. Escalate concerns and resource constraints to project leads and directors when necessary. Completed lessons learned following project completion to promote continuous improvement within the client site.

Amsterdam, Nl

Supported technical writing and material onboarding for clients Isolator validation project. Also preformed as a project coordinator when needed.

Global Locations, Us

-Train new site employees as well as sister sites on SQF, GMP, Food Safety and HACCP Basics-HACCP Team Lead,Crisis Management Coordinator, and SQF Practitioner for the Site-Implemented and achieved SQF Level 2 Certification for the new Boston Site within the year (93/100)-Ensure the Quality Management System conforms to customer, internal, ISO and regulatory requirements.-Update quality documentation to ensure best and correct practices are in place.-Formulate, document and maintain quality control standards and on-going quality control objectives-Work with management and supervisory team on developing and executing corrective action plans related to quality concerns: complaints, global corrective actions, other chronic quality issues.-Identify and record quality-related problems, initiate action to prevent non-conformance, and recommend solutions.-Oversee customer requested audits and other 3rd Party Audits. Develop Corrective Action Plan for non-conformities discovered during those audits.-Ensure a high level of internal and external customer service. Investigate (and correct) customer issues and complaints relating to quality.-Supervise workers engaged in inspection and testing activities to ensure high productivity and high technical integrity.-Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products.-Interact with vendors to ensure the quality of all purchased parts.-Maintain active role on internal continuous improvement teams managed by Director of Process Improvement -Establish SOPs for all quality processes and procedures to maintain consistency, accuracy and controlled results.

Cambridge, Massachusetts, Us

•Review data and provide justification documents for regulatory submissions IMPD/IND/NDA•Develop and maintain QC policies, SOPs, specifications, and specification justification reports• Provide QC project management of timelines for cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.) to support IMPD/IND/NDA filings• Support QC during GxP audits/inspections• Serve as SME for QC specifications and stability during regulatory inspections• Provide training and guidance to other analysts• Support and develop risk assessments to determine level of compliance risk• Lead the implementation of appropriate mitigation strategies

Waltham, Ma, Us

Analyze, Review, and create Analytical Method Life Cycle, Stability, Drug Product and Drug Substance control charts for Quality Control and Technical OperationsParticipated in the launch of IntrarosaEdited current batch records and suggest additionsCollaborated with Process Engineer on investigations and validationInterviewed potential applicants for CO-OP positionEdited SOPs for Technical OperationsCreated SCN’s for Technical Operations and Quality AssuranceCreated information kiosk template and written recommendation for VP of Technical operations and Project ManagementInspected product at vendor site

Boston, Ma, Us

Referee Volleyball and Basketball Intramural games at Northeastern University.

Boston, Ma, Us

Serve as Northeastern’s liaison for e-BuilderTrained clients and co-workers in the use of e-BuilderDeveloped reports, user guides, processes, and workflow diagrams and presented them to colleaguesBecame sufficiently expert in a new e-Builder module to test in and create a user guide for fellow employeesManage integration of e-BuilderGary YoungerMacKenzie has been a real asset to the Project Controls group. She has played a major role in launching new business processes and identifying ways to make things more efficient. I have been really been impressed by her problem solving skills and the professionalism she has display during her co-op. I am confident she will be very successful as her professional career evolves in the future.

Forchheim, De

Collected and reported data and calculations on Deionized water system upgrade and heat exchanger. Created and completed pFMEA documents for validationAid in the Reverse Osmosis system upgradeDrafted and edited P&IDsAlbert PorrasMacKenzie was assigned the task of reviewing a newly constructed process system (city water pretreatment and reverse osmosis unit) compared to the piping & instrumentation diagrams (P&IDs) submitted by a contractor to verify the physical construction completed. The goal was to determine what errors and/or commissions required corrective actions. MacKenzie was taught how to read the P&IDs and she learned quickly. While reviewing the P&IDs she identified a number of errors by the contractor. This allowed Siemens to avoid paying for re-work because of contractor errors. She also assisted on a heat exchanger - chiller validation by collecting operating data, analyzing it, developing equations and writing a report summarizing the findings of the data analysis. Her work was efficient, accurate and she had a feel when something she observed was not correct.

Boston, Ma, Us

Help manage basketball and hockey games. Set up banners and signs as well as do promotional events to get students involved in Northeastern Sports.

Bachelor'S Degree, Chemical Engineering

Working On Bs, Chemical Engineering