Paula Bergin-Holbrook has over 25 years of experience in quality assurance for the biotechnology and pharmaceutical industries. She has extensive experience with GMP quality systems, auditing, CAPA management, and ensuring regulatory compliance. Her background includes roles with increasing responsibility at companies such as Nuclea Diagnostics, Shire, Genzyme, Genentech, and Biomerieux.

1. Paula Bergin-Holbrook
131 Stonebridge Drive
Hanson, MA. 02341
617-823-0633
pberginholbrook@gmail.com
PROFILE
A motivated and results driven Quality Assurance Professional with extensive experience in the
Biotechnology and Pharmaceutical industries. Experienced in GMP Quality Systems, Clinical compliance
operations, CAPA’s, Deviations, Internal auditing, CMO support, Supplier oversight, Root Cause analysis,
Writing and revising SOP’s, and Process flows. A track record of innovation gained through a variety of
experiences with the ability to substantially contribute to your organization.
Microsoft Office, Excel, Adobe Professional, Oracle, Track wise, Live Link, Power Point, Visio, SAP
Auditing, ISO 13485, ISO 9001
PROFESSIONAL EXPERIENCE:
Nuclea Diagnostics Laboratories, LLC Cambridge, MA October 2014 to January 08, 2016
Senior Quality Assurance Specialist
• QA support for GMP compliant operations
• Quality review and oversight of CAPA assessments
• Quality oversight Supplier management
• Record review
• Approval of quality systems
• Creation of Process flows
• Release of GMP product
• Participation in business updates, meetings, quality audits and assessments
SHIRE HGT, Lexington, MA
Senior Quality Assurance Specialist (6 month contract) December 2012- through May 2013
• Quality Oversight of P&L Component, Art Work and Labeling and Distribution vendors.
• Review and approval of all quality systems; SOPs, specifications, Master batch records, Executed
batch records, deviations, CAPAs and change controls associated with CMO operations
• Participation in business updates, meetings, quality audits and assessments
• Development and compliance requirements of Technical Quality Agreements with Shire’s external
P&L, Component, Art Work & Labeling and Distribution Vendors
• Compile final drug product data in support of Annual Product Reviews
• Maintenance of metrics for routine monitoring and continuous improvement. Responsible for the
proactive response to quality trends and non-urgent upgrades for continuous quality improvement
GENZYME, Inc., Allston, MA. 2011 - 2012 (Consent Degree Project)

2. Senior Compliance Specialist (6 month contract)
• Tracked to completion all deviations and investigations related to product release.
• Actively partner with multiple departments to make improvements to batch record or
procedures.
• Represent QA Bulk Operations group in on-site meetings.
• Maintained lot tracking databases and spreadsheets.
• Prepare lot release paperwork to support Product Release Coordinator.
IMMUNOGEN, INC. Canton, MA. April to July 2011
Senior Quality Assurance Specialist (4 month contract-Maternity coverage)
• Batch record review
• QA support for GMP compliance operations
• Coordination of CMO documentation requirements
• Visio project work
GENENTECH, INC. Cambridge MA. January 2006 thru March 2011
Senior Quality Assurance Specialist, External Quality Clinical Operations
• Quality Assurance support for GMP and Clinical compliance operations
• CMO site support, Commercial and Clinical
• Writing/ revising SOP’s and Procedures
• Deviation investigation and closure
• CAPA assessments
• Documenting process controls
• Review and release of bulk material manufactured at CMO commercial operations
• Batch record review and management of Clinical label/ pack distribution operations
• Coordinate / resolve issues with CMO sites
• Creation & maintenance of databases for lot tracking
• GMP Commissioning of Contract facilities
• QA representation for shipments to Clinical Depots in the US, LA and Europe
BIOPURE, INC. Cambridge, MA. Sept 2005 thru Dec 2005
Quality Assurance Specialist II
Temporary Assignment / Contract Employee
• Batch record review
• QA support for GMP compliance operations
• Managed stability data entry
ACAMBIS, Canton, MA. May 2005 thru August 2005

3. Quality Assurance Specialist II
Temporary Assignment / Contract Employee, Contract completed
• Coordinate, assemble and review of batch records for BLA submission to FDA, Organize/ Edit data
packages
SERONO INC. Rockland, MA. April 2004 thru July 2004
Quality Assurance, Product Technical complaint coordinator/
Temporary Assignment / Contract Employee, Contract completed
• Customer communiqué in resolving and troubleshooting problems with medication or devices
• Quality Assurance support for GMP compliance concerning the handling and disposition of product
complaints
• Coordination/ replacement / retrieval of pharmaceutical drug or devices
• Disposition and closure of product complaints with international sites
• Maintain product complaint database (Trackwise)
• Maintain GMP environment
V.I. TECHNOLOGIES, INC. Watertown MA. April 2003 thru April 2004
Quality Assurance Specialist II
• Quality Assurance support for GMP operations; issuance of manufacturing batch records and final
release of processed blood units
• Generate final product Certificates of Analysis (COA)
• Deviation investigation and closure
• CAPA investigations
• MRB coordinator
• Writing/ revising SOP’s
• Internal auditing of QA systems primarily focused on controlled material processes
• Implemented raw material requirements & raw materials specifications
• Implemented process improvements through the creation of efficient changes to the process flow,
overhauling the incoming processes/ practices which included receipt of raw materials, establishing
new sampling plans and associated documentation for recording inspection results, and defining the
quarantine practice for receipted material during the time between QC testing/and final release
• Established or revised vendor requirements
SERONO LABORATORIES, Randolph MA. 2001 thru 2002 (Facility closure)
Quality Assurance Specialist II
• Inspection and release of commercial and clinical drug and device(s)
• Managed discrepant materials
• Deviation investigation and closure/ CAPA investigations
• Managed re-packaging operations
• Coordinator of the returned investigational drug and device
• Document Control, Writing and revising SOP’s

4. • Processing Product Complaints
BIOMERIEUX, INC. Rockland MA. 1989 thru 2001
Incoming Quality Coordinator
• Assisted with launching the Incoming Quality Control department by creating documentation detailing
critical requirements for all materials that would be used to manufacture GMP material
• Established and implemented quality test procedures and documentation requirements.
• Managed the Incoming Quality Control department via Quality oversight of all critical and non-critical
inventories, (antibodies, conjugates, serums, chemicals, labeling and packaging materials).
• Managed deviation investigation and closure
• Managed non-conforming and discrepant materials inventories
• Established and implemented the Dock To Stock Program
• Monitor mold injected plastics, labeling and packaging materials.
• CAPA investigations
• Demonstrated expertise in enhancing profits by lowering material costs and implementing quality
assurance programs.
• Responsible for the reduction non-conformities from approximately 80% in 1991 to approximately 5%
in 1995
• Creation and/or revision of SOP’s.
• Auditing, internal and ISO 9001
Professional Development:
• GMP Compliance Auditor training 2009
• Validation and Qualification Compliance Requirements 2009
• Preparation, Packaging and Labeling of Clinical Trial Materials 2008
• International GMP’s: Complying with Requirements in the US, EU, and Japan 2007
• Mastering Your Performance as a QA Professional 2007
• Hands-on, Bio-Manufacturing Training 2007
• Pharmaceutical Technology Transfer 2007
• ASQC Introduction to Quality Engineering 2000
.
REFERENCES UPON REQUEST