Nicole Morales-Quiles

Project management professional with an extended record of excellence in complex matrix environments. Demonstrated success leading ambitious business change and technology projects in both structured and unstructured settings. Ensure consistent attainment of deadlines, budget goals, and quality expectations. Forge productive relations with all departments and corporate levels. Managed integrated programs in various areas including asset management, supply chain, operations, IT, compliance, quality and HR. Confident leader and mentor who builds top-caliber teams by fostering the utmost staff morale and excellence. Project Management professional, and Master of Business Administration in Quality.

AURO PR, INC, Project Manager - Supply Chain
02/2023–Present
 • Lead project teams and manage work plans for each phase of the project including timelines, and risk management.
• Develop and manage initiatives to drive improvements within the supply chain.
• Develop and support constructive and cooperative working relationships with all
stakeholders.
• Conduct field surveys to evaluate operations and recommend changes. Work with
Distribution facilities and facilities management to define best practices.
• Prepare documentation, identify SOP development modification for assigned
projects.
• Implement and manage project changes and interventions to achieve project
outputs.
• Assist with responses to request for quotes for supply chain services.
• Complete material shipment authorization of Raw Materials and Packaging
Components to continue with shipment.
• Manage material assessment list as per manufacturing and packaging plan to comply
with requirements.
• Conduct daily team meetings to ensure materials availability and delivered on time.
• Keep track of investigations, CAPA’s, and others; to evaluate potential risks on
product disposition/ releases.
• Plan product shipment and track closely all department activities needed in weekly
meetings.
• Effectively coordinate all support activities.
• Review Supplier list as per regulatory changes managed through CC system. • Review and approve Change Control activities.

AURO PR, INC, Project Manager -Operational Excellence
04/2019–02/2023
• Managed projects within five process groups in Predictive/Agile/Hybrid development.
• Developed team communications and information for meetings (Dashboard).
• Proved successful working within tight deadlines and a fast-paced atmosphere.
• Created plans and communicated deadlines to ensure projects were on time.
• Used critical thinking to break down problems, evaluate solutions and facilitate the
team making decisions.
• Led project teams in delivering project objectives serving as facilitator and contributor for the project’s success.
• Offered friendly and efficient service to all customers, managing challenging situations with ease.
• Maintained energy and enthusiasm in a challenging environment.
• Conducted research, gathered information from multiple sources, presenting results.

• Actively listened to customers, managed concerns quickly, while in communication with stakeholder.
 • Used coordination and planning skills to achieve results according to schedule.
• Performed duties by all applicable standards, policies, and regulatory guidelines to
promote a safe working environment.
• Created spreadsheets using Microsoft Excel/Microsoft Project for reporting.

Viatris/ Mylan, Supervisor Microbiology
03/2015–04/2019
• Plan and ensure material testing are in adherence to schedule as per manufacturing activities.
• Assign daily tasks and create a weekly and monthly schedule for personnel.
• Assure compliance with all applicable Quality System regulations/ procedures.
• Manage the Facility Flora data Management Program.
• Perform audits to other areas to assure processes are complying.
• Collaborate as SME in internal audits related to Microbiology laboratory and
contribute with observations and answers.
• Write,update,andevaluatetestmethodsandSOPsusingknowledgeofcGMPs,USP,
CFR, and NF always identifying areas for improvement.
• Review and create worksheets, logbooks, and general documentation as per
regulatory guidelines, focusing on visual tools to facilitate documentation and
minimize human errors.
• Maintain accurate, detailed records of work performed.
• Create trend reports and review data analysis.
• Perform control charts of data obtained in Environmental activities and ID.
• Execute Environmental Monitoring Annual Report (3&6 sigma calculations).
• Prepare bi-annual graphics reports for the Environmental Monitoring program.
• Coordinate necessary lab support and provide release of FP/RM/PC.
• Write investigations using Trackwise System, CAPAs, Incident reports, and Risk
Assessment Assist in method development, validation, and verification for new and
existing products.
• Develop Microbiological testing methods.
•Writevalidationprotocol,programtestingexecution,andreviewandapprovedfinal
summary reports.
• Directly involved writing and revising protocols and memos •
• Represent the Microbiology department actively on the object and cross-functional teams and committees.
• Promote and keep a team environment among laboratories personnel.
• Participated directly in FDA and MHRA audit inspections.
• Performed training and guided other personnel as subject matter experts in general
and advanced laboratory practices.
• Executed continuous team meetings to reinforce TEAMWORK among laboratories.
• Perform employee evaluations and manage budget per qualifications and grades.

Master of Business Administration, Quality Management

University of Puerto Rico
Bachelor of Science, Microbiology