Erin McGraw
Wakefield,MA
Summary
Dedicated Quality Assurance professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
18
18
years of professional experience
1
1
Certification
Work History
SENIOR MANAGER QUALITY ASSURANCE
AlloVir
06.2021 - Current
- Responsible for managing quality oversight of AlloVir’s contract development and manufacturing organization (CDMO) partners according to current Good Manufacturing
- Ensure internal and supplier compliance to FDA, EMA and ICH guidelines and industry best practices
- Partner with internal and external manufacturing and quality teams to ensure high levels of quality for all operational activities leading to product disposition including review and approval of master batch production records and operating procedures, on-the-floor person in plant (PIP) quality oversight, deviation investigation support, and review of batch production records
- Lead inspection readiness projects and support regulatory body inspections to positive outcomes
- Support a Quality Risk Management culture
- Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.
- Implementation of VeevaQMS and developed new procedures and processes to ensure further compliance.
- Mentor junior staff members for skill development and career progression within the organization.
- Collaborat closely with peers from other departments to drive organizational success jointly as one cohesive unit.
QA CLIENT ALLIANCE SPECIALIST
ThermoFisher
08.2020 - 06.2021
- Responsible for Quality SME of major operational partnerships and ensures Quality aspects of the partnership are proactively and effectively completed
- Acts as Quality Subject Matter
- Expert for the Quality Unit matters in different multidisciplinary customer project teams, and as a liaison among customers and other departments
- Quality representative in the different multidisciplinary teams for Client projects
- Provide specific technical knowledge for the Quality Unit organization
- Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner
- Perform, review, approve and follow up tech transfers and methods validation documentations related to the different customer´s projects
- Prepare and execute specific protocol studies requested by customers and present data and reports (internally and in front of customers)
- Perform the monitoring of the process from the quality perspective
- Supports Lot Disposition for the batch release
- Manages QMS items requiring Client review
- Review and approve process sampling plans and process descriptions
- Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required
- A dedicated professional with 17 years of experience within quality in the pharmaceutical industry
- Specializes in detailed analysis of systems and facilities for compliance with quality regulations and standards.
MANAGER QA COMPLIANCE
Brammer Bio (ThermoFisher)
11.2019 - 08.2020
- Responsible for ensuring compliance with all applicable provisions of the Quality
- Management System, as well as the regulations
- Represents ThermoFisher Scientific VVS during regulatory inspections assuring management that requested information is produced in a timely, accurate and complete manner
- Assures that inspection / audit responses are timely and appropriate to maintain good standing with regulatory agencies
- Coaches and educates cross functional staff in regulatory inspection readiness activities
- Ensure finding responses from other Thermofisher Scientific sites as well as external Regulatory Intelligence are assessed for applicability and appropriate action is taken in a risk based manner
MANAGER SUPPLIER QUALITY
Brammer Bio
01.2019 - 11.2019
- Responsible for ensuring compliance to the applicable Directives, Procedures, and
- Regulations governing Supplier/Vendor Management, as well as providing support across all Brammer Bio sites (Cambridge, MA, Lexington, MA, and Alachua, FL)
- Quality oversight for Supplier Management Operations, including supplier/vendor assessment/auditing, supplier performance monitoring, and life-cycle management
- Quality oversight for Supplier/Vendor Quality Agreements
- Quality management support for the onboarding of new materials and suppliers/vendors
- Quality support for Supplier Change Notifications (SCNs), Supplier Corrective
- Action Requests (SCARs)
- Help to establish and oversee execution of the supplier/vendor audit schedule
- Quality oversight of the MRB process
- Quality representation for the Supplier/Vendor Management Team
- Management of the Approved Supplier/ Vendor List
- Represent the organization and act as SME during external (client and regulatory) inspections as needed
- Batch Records Simplified and
- Clarified
- Center for Professional
- Advancement
- NJ
MANAGER QUALITY COMPLIANCE
AMAG Pharmaceuticals
01.2018 - 01.2019
- Responsible to ensure compliance with GXP regulations
- Work with AMAG management in ensure compliance with Quality systems procedures
- Assist in developing procedures to ensure regulatory compliance to governing standards from the FDA Part 1270, 1271, 21CFR820, ISO 9001, and other regulatory bodies
- Official Head of Compliance for AMAG
- Leader of the audit war room during regulatory inspections
- Manage the AMAG internal audit system
- Assign audits as necessary
- Create and maintain the Quality and Compliance metrics for AMAG
- Coordinate the Management Review process for the Quality and compliance areas
- Respond to or coordinate any external audit non-conformities
- Monitor and communicate changes in regulatory requirements to company management
- Prepare, review, and submit requested documentation to FDA, and other regulatory agencies
- Work closely with the QA Associate Director and QC Associate Director to develop strategies to ensure compliance of the Quality System to GXP regulations.
SENIOR QA COMPLIANCE SPECIALIST
AMAG Pharmaceuticals
10.2016 - 01.2018
QUALITY AUDITOR
Sanofi
07.2014 - 10.2016
QC FUNCTIONAL TRAINING SPECIALIST
Genzyme
08.2011 - 07.2014
SENIOR ANALYST, MICROBIOLOGY
Genzyme
01.2010 - 08.2011
QUALITY CONTROL ANALYST II, MICROBIOLOGY
Genzyme
11.2007 - 12.2009
QUALIY CONTROL ASSOCIATE
Wyeth Pharmaceuticals
08.2005 - 11.2007
Education
Master of Science - Regulatory Affairs, Concentration in Compliance
Northeastern University
Boston, MA2016
Bachelor of Science - Biology
University of New Hampshire
Durham2005
Skills
- Partnership Development
- Cross-Functional Collaboration
- Regulatory Compliance
- Process Improvement
- Experienced with Documentation and Quality Management Systems such as Veeva, MasterControl and Trackwise
- Use of laboratory management systems such as Limslink and ILIMS
- Use and administration of Learning Management systems including Plateau, My Learning Center and Veeva
- Teamwork and Collaboration
- Staff Training
- Work Planning and Prioritization
- Change Management
Certification
ASQ Certified Auditor
Boston, MA
2018
QMS Lead Auditor Certification
Timeline
SENIOR MANAGER QUALITY ASSURANCE
AlloVir
06.2021 - Current
QA CLIENT ALLIANCE SPECIALIST
ThermoFisher
08.2020 - 06.2021
MANAGER QA COMPLIANCE
Brammer Bio (ThermoFisher)
11.2019 - 08.2020
MANAGER SUPPLIER QUALITY
Brammer Bio
01.2019 - 11.2019
MANAGER QUALITY COMPLIANCE
AMAG Pharmaceuticals
01.2018 - 01.2019
SENIOR QA COMPLIANCE SPECIALIST
AMAG Pharmaceuticals
10.2016 - 01.2018
QUALITY AUDITOR
Sanofi
07.2014 - 10.2016
QC FUNCTIONAL TRAINING SPECIALIST
Genzyme
08.2011 - 07.2014
SENIOR ANALYST, MICROBIOLOGY
Genzyme
01.2010 - 08.2011
QUALITY CONTROL ANALYST II, MICROBIOLOGY
Genzyme
11.2007 - 12.2009
QUALIY CONTROL ASSOCIATE
Wyeth Pharmaceuticals
08.2005 - 11.2007
Master of Science - Regulatory Affairs, Concentration in Compliance
Northeastern University
Bachelor of Science - Biology
University of New Hampshire
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