Wendy Bliss
Seattle,WA
Summary
Quality Assurance professional with 25 years experience in pre-clinical, clinical and commercial pharmaceutical operations, including supplier qualification, continued assessment and engagement; quality system implementation; batch record review and product disposition; and successful regulatory inspections.
Overview
27
27
years of professional experience
Work History
Associate Director, QA
Aurion Biotech
07.2023 - Current
- Oversee Drug Substance and Drug Product disposition activities
- Development and maintenance of Quality Agreements
- Vendor qualification and management
- QMS Implementation
QA Manager/Sr. QA Manager
Neoleukin Therapeutics, Inc.
10.2019 - 03.2023
- Implemented and maintained Document Control and employee Training systems
- Implemented vendor assessment and qualification process
- Project Manager for implementation of eDMS (Veeva QualityDocs Essentials)
- Reviewed and approved CMO master documentation in support of manufacturing and and testing
- Reviewed batch files and dispositioned drug substance, product, and packaged clinical trial material
- Collected and coordinated source documentation and compiled stability data tables in support of IND
- Implemented procedures supporting QMS, including deviations, CAPA, complaints, and change control
- Implementation, review, and maintenance of Quality Agreements
- Reviewed and approved controlled documentation
- Auditing of GxP suppliers
- Implemented Quality Manual and Quality Management Review.
Sr. QA Associate/Manager, QA Compliance
Immune Design, Inc.
08.2014 - 10.2018
- Conducted internal audits, report preparation and follow-up
- Conducted vendor qualification and routine audits, report preparation and follow-up
- Maintained document control system, tracking review and approval of internal and external master documentation
- Created and maintained employee training plans and files and coordinated annual required training (cGMP, GCP)
- Supported partner and Due Diligence audits
- Acted as QA liaison for CMOs
- Reviewed batch record files and disposioned drug substance, product, and packaged clinical trial material
- Engaged with QP to ensure requirements were met for release into EU
- Reviewed, approved and tracked deviations and CAPA to completion
- Coordinated and participated in Product Quality Investigations
- Reviewed QC release and stability data
- Initiated monthly QC Laboratory Walk-through and IP storage and shipment temperature excursion assessment procedures.
Sr. Quality Assurance Specialist II, Compliance
Dendreon Corporation
01.2011 - 08.2014
- Conducted internal audits, report preparation and follow-up
- Conducted vendor qualification and routine audits, report preparation and follow-up
- Performed vendor status risk assessments
- Supported FDA and state regulatory inspections
- Supported partner and Due Diligence audits
- Performed Apheresis Center surveillance audits against Good Tissue Practices
- Served as GCP Lead for Quality Compliance
- Conducted GCP auditing, including vendor assessment and clinical trial sites
- Performed GCP Compliance review of clinical trial documentation
- Conducted data audits in support of Regulatory submissions, data analysis, position papers and posters
- Conducted training on Quality Compliance programs.
QA Associate III, Compliance/Sr. QA Associate, Compliance
Zymogenetics, Inc
03.2007 - 12.2010
- Conducted internal audits, report preparation and follow-up
- Conducted vendor qualification and routine audits, report preparation and follow-up
- Tracking and trending of audit findings
- Complaint handling and follow-up
- Compliance assessment of raw materials (supplier, TSE/BSE)
- Validated TrackWise audit workflow and served as administrator
- Maintenance of ComplianceWire (Learning Management System)
- GCP auditing, including vendor assessment and clinical trial sites
- GLP auditing for preclinical studies
- Supported FDA and state pharmacy inspections
- Supported partner and Due Diligence audits.
Quality Specialist II/III
GlaxoSmithKline Biologicals (fka ID Biomedical)
04.2003 - 12.2006
- Manufacturing production record review and approval
- Raw material inspection and testing review
- Raw material, intermediate, and final product disposition
- Deviation Report system maintenance and CAPA follow-up
- Room clearance and in-process production inspections
- Internal and external audits, report preparation and follow-up
- Training system development and GxP training execution
- Failure Investigations and report preparation
- Review of Regulatory documents in preparation for publishing
- Safety Committee and Spill Team member.
Archivist/DC Coord./Sr. Doc Specialist/Quality Associate
Cell Therapeutics, Inc. (aka CTI Biopharma)
06.1997 - 03.2003
- Maintenance of internal/external Document Control systems and acted as primary liaison to CMO Document Control
- Batch record review and product disposition
- Maintenance of Change Control system
- Final label proofing, including packaging, package inserts and labeling in multiple languages
- SOP creation and employee training for Document Control and Quality procedures
- Creation and maintenance of archiving system, including database and archives design and system SOPs
- GLP audits of external archive sites, including archives maintained at CMOs.
Education
English Literature -
University of Washington
Seattle, WashingtonSkills
- CGMP
- Auditing
- Quality Systems Management
- Teamwork and Collaboration
Timeline
Associate Director, QA
Aurion Biotech
07.2023 - Current
QA Manager/Sr. QA Manager
Neoleukin Therapeutics, Inc.
10.2019 - 03.2023
Sr. QA Associate/Manager, QA Compliance
Immune Design, Inc.
08.2014 - 10.2018
Sr. Quality Assurance Specialist II, Compliance
Dendreon Corporation
01.2011 - 08.2014
QA Associate III, Compliance/Sr. QA Associate, Compliance
Zymogenetics, Inc
03.2007 - 12.2010
Quality Specialist II/III
GlaxoSmithKline Biologicals (fka ID Biomedical)
04.2003 - 12.2006
Archivist/DC Coord./Sr. Doc Specialist/Quality Associate
Cell Therapeutics, Inc. (aka CTI Biopharma)
06.1997 - 03.2003
English Literature -
University of Washington
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