Experience

Technical Safety Services
• United States
• Biotechnology Research
• 100 - 200 Employee
• Consultant

  • Jul 2023 - Present

DPS Group Global
• Ireland
• Architecture and Planning
• 700 & Above Employee
• Account Manager

  • Jan 2022 - Jul 2023


Organogenesis

• Biotechnology Research
• 700 & Above Employee

• Facilities Compliance Manager

  • Apr 2020 - Dec 2022

  Clientside liaison between Facilities Department and onsite Quality and key stakeholders to define and address all documentation issues. ▪ Led and participated in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities were performed in a timely manner and in compliance with procedures and regulatory requirements. ▪ Managed and provided support, information, and assistance to the sitewide asset management system. ▪ Facilitated review and revisions of Facilities Department related standard operating procedures, work instructions, risk assessments, and OJT task evaluations for each group within the Department. ▪ Collaborated with individuals and groups with the initiation, review, submission, and follow-up of documents such as change controls and corrective and preventive action plans. ▪ Provided periodic review of Facilities Department documentation and records such as SOPs and maintenance work records to assess compliance with established quality standards, policies, and procedures. ▪ Provided support and training for Facilities personnel on regulatory and quality topics such as accurate documentation procedures. ▪ Tracked validation and construction documentation to meet deadlines. ▪ Closed major deviations in documentation that had impacted Facility Department for years. ▪ Conquered one of the biggest reconfigurations of Facility Documentation by bringing multiple sites under one maintenance program with detailed workplans. ▪ Re-wrote complex system SOPs to be within compliance, created commissioning test plans and user requirement specifications, and trained gap assessments. ▪ Worked with the multiple construction teams to meet deliverables and deadlines. Show less



Moderna Therapeutics

• Biotechnology Research
• 1 - 100 Employee

• CQV DOCUMENT CONTROL COORDINATOR

  • Jun 2018 - Apr 2020

  Responsible for the Quality and Compliance of all types of Engineering and C&Q documentation by partnering with client CQV Engineering team to control how documentation was accepted and archived. ▪ Organized, tracked, and reviewed all construction documents provided by the construction management company ensuring they met GMP and C&Q requirements as defined by the client. ▪ Functioned as a final QA reviewer on engineering lifecycle documentation such as cGMP documentation turnover packages (TOP), risk assessments, and C&Q protocols for critical equipment and utilities. ▪ Reviewed and edited equipment turnover packages (ETOPS) from vendors, the design firm, and the construction management company to ensure they were in accordance with the C&Q requirements and presented in a format that was consistent with the client’s site requirements. ▪ Managed Engineering Drawings resulting in the latest drawing sets being used in the field and for commissioning and validation. ▪ Collaborated with multiple departments to understand and support critical deliverables to meet aggressive project schedules while ensuring clients’ quality expectations. ▪ Created and managed a process to catalog and organize approved engineering lifecycle documentation resulting in expedited responses to regulatory audit requests. ▪ Provided requested documentation and additional backroom support during multiple regulatory audits. Show less



Tedor Pharma, Inc.

• Quality Assurance

  • Sep 2016 - Jun 2018

  Provided support for investigating deviations including root-cause analysis and corrective and preventative action (CAPAs) proposals and initiatives. ▪ Issued batch records for product release and room clearance. ▪ Developed written procedures for Quality Assurance and Product Release Group. ▪ Reviewed the existing standard documentation for operations and proposed improvements deemed necessary. ▪ Performed review of manufacturing batch records and supported records to certify compliance with specification and procedures. ▪ Communicated with various departments including Technical Services, Validation, Quality Control, and Production to achieve timelines and common goals. ▪ Prepared and proofed batch records and production validation runs. ▪ Participated in equipment audits and maintained manual equipment database. Show less



Sanofi Genzyme

• Documentation Specialist II

  • 2011 - 2012

  Effectively follows the company’s standard operating procedures in submissions of documents • Extensive knowledge of document control database systems • Was the lead document specialist for obsoleting and reinstatement of all documents in Framingham and Northborough • Ensure that the document control function is being performed in accordance with the procedures and in a timely manner • Ensure that the vendor SOPs, hard copies and soft copies are properly logged into the document control system • Communicated effectively with the internal customers on the status of their SOPs • Possess excellent leadership and interpersonal skills for managing work and tasks • Distributes and retrieves documents to/from all concerned departments • Amazing ability to coordinate with varied levels of management • Organize necessary filing and archiving of technical documents and performed administrative tasks as required. Show less



Honeywell Protection

• Documentation Specialist II Contractor

  • 2010 - 2011

  • Carries out distribution of controlled documents as required • Checks accuracy of the ECN’s and supporting documents • Follows the ECN processing procedure and coordinates the incorporation of drawing changes and inputs the BOM incorporations into MRP system • Files master manufacturing documents • Maintains records and logs regarding SOP, Work Instructions, and Cell Risk documentation. Creates new documents as needed and releases new documentation to Manufacturing as needed • Inputs changes into existing documentation Show less



Lincoln Peak Partners

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Executive Secretary/ Personal Assistant

  • 2008 - 2009

  • Handled the tasks of assisting managers, executives and senior level professionals • Responsible for handling phone calls and enquiries • Assigned the tasks of organizing meetings and conferences • Responsible for handling budgets and accounts of the organization • Performed quarterly evaluations to analyze the performance of instructors and students, including preparing graphs, spreadsheets and analytical data. • Handled the tasks of writing projects and conducting research work • Assigned the responsibilities of preparing official correspondence like letters of support and invitations • Drafted monthly activities and status reports as well as employee announcements and other communications • Devised and maintained the systems to enhance the work flow of the organization • Handled other administrative tasks as assigned Show less



Dell EMC

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Resource Coordinator/Contractor

  • 2005 - 2007

  • Facilitated the management of all Global Education classes’ worldwide, including sales, customer and internal training programs • Planned and coordinated all sales training courses. Worked with sales management and personnel to provide the proper course material for students • Performed quarterly evaluations to analyze the performance of instructors and students. Including preparing graphs, spreadsheets and analytical data • Managed the enrolling of students for all classes, coordinating catering, and travel • Coordinated budget and all expenses for all independent contractor instructors • Organized new hire training and prepared all necessary materials • Extensive use of Microsoft Office applications including Word, Excel, PowerPoint, and Outlook • Received documented honorable mentions from customers complimenting on their experience Show less