Quality Assurance Manager @ • Managed the following QA Activities for Consumer Healthcare meeting or exceeding set goals: o Review and approval of Manufacturing and Laboratory investigations and commitments o Audit of Bulk, Packaging and Intermediate Batch Records o Release of Raw Materials, Packaging Components including labels, Bulk Material, and Finished Product o Issuance of COAs and COCs o Classification of Defects o Shopfloor o Retention Sample Management o Transfer of Documentation (Batch Records, Logbooks, Raw Materials) to storage location. o Writing, Editing and Revising of Standard Operating Procedures o Testing for other network sites • Supervised two shifts of colleagues • Reviewed and approved Laboratory and Manufacturing investigations, Commitments, Change Controls, Master Batch Records, Supplements and Standard Operating Procedures. • Worked with different Pfizer sites to transfer bulk and raw materials. • Coordinated with Planners, Manufacturing, and Laboratories to support Production. • Represented QA Product Release and Investigation for internal and external audits. • Delegate of Associate Director for Change Control and select reports. • Decommissioning Team Member responsible for review of Decommissioning Reports, Walk Through of areas, and issuance of completion Memos for Investigations and Release. • Pearl Review Representative for QA Diagnostic for Quality Systems at the Pfizer’s Montreal Site • Pfizer’s Ferrosan Site in Denmark Assisted in updating and streamlining processes to comply with Pfizer Standards. Incorporated best practices as related to auditing and release (2 month relocation to Denmark Site) From May 2011 to Present Senior Quality Assurance Specialist @ • Reviewed and Approved Laboratory and Manufacturing investigations, Commitments, Change Controls. • Verified charging of material into blenders. • Compiled Investigation Metrics. • Trained colleagues for SAP-CAPA • Audited/ Reviewed and Released Raw Materials, Bulk and Packaged Products. • Revised, Reviewed and/or Created Standard Operating Procedures. • Team Member of Packaging Compliance Tea, • Team Member for Standard Work in the Quality Assurance Product Release Process utilizing Lean Six Sigma Principles. Team lead in use of Lean Six Sigma Tools and development of the metrics. (2009-2010) • Team Lead for Streamlining of Stability Sample Process utilizing Lean Six Sigma Principles. (2008-2009) • Team Lead for Metal Detection Risk Assessments (2007) From June 2007 to May 2012 Area Governor @ From 2010 to 2010 Technology Scientist/ Engineer @ • Team leader and Technology representative to Metal Detection Project, which included the addition of metal detection to the compression area and qualification of the associated products. • Technology representative for investigating Cleaning Violation Issues. • SME for Cleaning Validation and Metal Detection. From January 2006 to June 2007 Validation Specialist @ • Validation specialist contractor providing validation support to an existing cGMP Biopharmaceutical facility. • Responsible for the periodic review of equipment and systems as well as the planning and tracking of the reviews. • Supportive team member of FDA/ EMEA inspection team. From May 2002 to December 2005 Process Engineer/ Validation @ • Executing protocols and prepared final summary reports for biopharmaceutical validated systems. • Responsible for the periodic review of equipment and systems as well as the planning and tracking of the reviews. • Process Engineer on project to reduce air emissions with the use of Maximum Achievable Control Technology (MACT). Participated in HAZOP review meetings for several facilities. From 1999 to 2002

Masters, Pharmaceutical Engineering @ Stevens Institute of Technology From 2009 to 2013 Graduate Certificate, Pharmaceutical Engineering @ New Jersey Institute of Technology From 2006 to 2008 Bachelors of Engineering, Chemical Engineering @ The Cooper Union for the Advancement of Science and Art From 1995 to 1999 Kathleen Irwin is skilled in: GMP, Change Control, Validation, Sop, CAPA, Quality Assurance, Quality Management, Quality System, Six Sigma, Risk Management, Project Management, Manufacturing, Computer System Validation, Software Documentation, LIMS, FDA, Pharmaceutical Industry, Biopharmaceuticals, GLP, Trackwise, Biotechnology, GxP, Aseptic Processing, Cleaning Validation, V&V, Vaccines, 21 CFR Part 11, FDA GMP, Regulatory Requirements, IND, USP, Chromatography, Pharmaceutics, Regulatory Submissions, Dissolution, Regulatory Affairs, Quality by Design, cGMP practices, Deviations, Analytical Chemistry, ISO 13485, UV, Quality Auditing, GAMP, Process Simulation, Aseptic Technique, Sterilization, HPLC, R&D, Quality Control