Experience

Vericel® Corporation

• United States
• Biotechnology Research
• 200 - 300 Employee

• Quality Systems Lead

  • Mar 2022 - Present

  Cambridge, Massachusetts, United States Business Process Owner for Change Management, Risk Management, and Design Control programs. Oversee and facilitate programs and provide site guidance to adhere to program requirements and related regulations. Change Control Quality Reviewer and Implementation Approver Lead risk assessments (including FMEA, PHA, and Risk Estimation) and design control deliverables Operate in environment of strict timelines Inspection Readiness Team: Facilitate site preparedness for hosting… Show more Business Process Owner for Change Management, Risk Management, and Design Control programs. Oversee and facilitate programs and provide site guidance to adhere to program requirements and related regulations. Change Control Quality Reviewer and Implementation Approver Lead risk assessments (including FMEA, PHA, and Risk Estimation) and design control deliverables Operate in environment of strict timelines Inspection Readiness Team: Facilitate site preparedness for hosting external inspections; Support audits by performing roles of Front Room Lead, Scribe, Front/Back Room Support; Audit Utopia admin; Coordinate Lessons Learned post-inspection Qualified On-the-Job Trainer Develop and deliver internal and site training content for Risk Management, Design Control, Change Control, and Audit Behaviors Mentor and train QS Engineer I’s in Quality System processes Oversee Quality Systems project distribution and department priorities. Collaborative team member and Project Manager for cross-functional group projects

• Quality Systems Engineer II

  • Mar 2019 - Mar 2022

  Cambridge, MA Change Management Risk Management; FMEA Facilitator Design Control Review document change requests Qualified On-the-Job Trainer Collaborative team member for cross-functional group projects

• Quality Systems Engineer I

  • Sep 2016 - Mar 2019

  Cambridge, MA Change Management Risk Management Review document change requests Qualified On-the-Job Trainer Collaborative team member for cross-functional group projects

• Senior Documentation Specialist

  • Dec 2014 - Sep 2016

  Cambridge, MA Process SOP, MS, and Master Production Record document change requests Process Drawing, Labeling, and Approved Draft change requests Batch record and label issuance and verification Qualified On-the-Job Trainer Revise department SOPs for Quality Drivers and process improvements Archive and maintain GMP documentation on-site and with an off-site vendor Collaborative team member for cross-functional group projects Represent QA Document Control in meetings Trackwise… Show more Process SOP, MS, and Master Production Record document change requests Process Drawing, Labeling, and Approved Draft change requests Batch record and label issuance and verification Qualified On-the-Job Trainer Revise department SOPs for Quality Drivers and process improvements Archive and maintain GMP documentation on-site and with an off-site vendor Collaborative team member for cross-functional group projects Represent QA Document Control in meetings Trackwise Originator and Assigned To roles Additional 2015 projects: QA Document Control Team Lead for the Document Management System Migration Facilitated the revision of Epicel final product and biopsy kit labeling for company name change

• Documentation Specialist II

  • Jun 2014 - Dec 2014

  Cambridge, Ma Process SOP, MS, and Master Production Record document change requests Process Drawing, Labeling, and Approved Draft change requests Qualified On-the-Job Trainer Batch record and label issuance and verification Archive and maintain GMP documentation on-site and with an off-site vendor Collaborate with others across departments on projects to streamline processes Create and deliver presentations for trainings or current projects Trackwise Originator and Assigned To roles



Genzyme

• 1 - 100 Employee

• Documentation Specialist II

  • Nov 2013 - Jun 2014

  Process document revisions utilizing the Livelink eWorkflow system Revised and implemented the document distribution system Revise department SOPs for process improvements Qualified On-the-Job Trainer Archive and maintain GMP documentation on-site and with an off-site vendor Review batch records for file closure and archival Collaborate with others across departments on projects to streamline processes Participate in multi-site initiative to improve document mastering… Show more Process document revisions utilizing the Livelink eWorkflow system Revised and implemented the document distribution system Revise department SOPs for process improvements Qualified On-the-Job Trainer Archive and maintain GMP documentation on-site and with an off-site vendor Review batch records for file closure and archival Collaborate with others across departments on projects to streamline processes Participate in multi-site initiative to improve document mastering process within Livelink Create and deliver presentations for trainings or current projects

• Documentation Specialist I

  • Jun 2012 - Nov 2013

  Process document revisions utilizing the Livelink eWorkflow system Revised and implemented the document distribution system Revised department SOPs for process improvements Qualified On-the-Job Trainer Archive and maintain GMP documentation on-site and with an off-site vendor Review batch records for file closure and archival Collaborate with others across departments on projects to streamline processes



Endicott College

• United States
• Higher Education
• 700 & Above Employee

• Writing Tutor

  • Sep 2009 - Dec 2012

  Endicott College Writing Center Worked with undergrad, graduate, and non-traditional students on senior thesis, papers, and other assignments. Focused on helping students improve their writing through grammar, sentence structure, organization, citations, clarity, and development of ideas. As peer tutor achieved CRLA Level III, which is a national accreditation and the highest level for peer tutors. Presented at the Northeast Writing Center Association's 2012 regional conference in NYC.



Quayside Publishing Group

• Editorial Intern

  • Sep 2011 - Dec 2011

  Copyedited manuscripts at all stages of book production. Wrote back jacket summaries for books. Maintained correspondence with endorsers and reviewers. Worked with acquisitions editors and project managers on assignments. Handled many Editorial Assistant tasks.



AMRI

• France
• Civic and Social Organizations
• 1 - 100 Employee

• Quality Assurance Intern

  • May 2011 - Aug 2011

  Burlington, MA Edited company correspondences with regulatory bodies. Provided direct support to compliance manager during FDA and client audits. Archived, indexed, and maintained Master Documents, SOPs, Material Specifications, Batch Records, files and other records. Issued, tracked, and reconciled controlled forms, logbooks, and lab notebooks.

• Quality Assurance Intern

  • May 2010 - Aug 2010

  Burlington, Ma Archived, indexed, and maintained Master Documents, SOPs, Material Specifications, Batch Records, files and other records. Issued, tracked, and reconciled controlled forms, logbooks, and lab notebooks. Provided direct support to compliance manager during FDA and client audits.



Lowell Sun

• Newspaper Publishing
• 1 - 100 Employee

• Editorial Intern

  • Dec 2009 - Jan 2010

  Reported and wrote news stories. Covered the MA Jan. 19, 2009 State Senate Election (Scott Brown v. Martha Coakley). Freelance writer after internship.