GXP PMP® QA/RA/Scientific/CMO/CRO Auditor/Consultant Seattle Area | Available April 2023 |Dennis.Thireault@yahoo.comPhone/Text: (206) 612-6845PMP® Project Management Relevant Skills:• Project Management Professional (PMP®), Six Sigma Black Belt trained, and take any ASQ exams.• Integration Management• Scope Management• Time Management• Cost Management• Quality Management• Human Resources Management• Risk Management (FTA, FMEA, Root Cause, Fishbone Diagrams, etc.) • Procurement Management (process mapping, Supply chain, etc.)• Stakeholder Management• Change/Configuration ManagementRegulatory Affairs (Medical Device/IVD) Relevant Skills:• United States FDA: 21 CFR/eCFR 820 Subparts A-O (QSR, Design Controls, DHF, DMR, CAPA, Records, etc.) • United States FDA: 21 CFR/eCFR Part 11 (electronic records)• ISO 13485, 14971, and ISO 9001, and ICH/ISO guidelines • 510Ks and IDE/NDE/HDE/PMA submissions work• Excellent understanding of medical device regulatory submission deliverables in the US and Europe• Class One to Class 3 Medical Devices development.• ISO 13485,14971 and 21 CFR Part 820 Regulatory Auditing • GxP Corporate Auditing for ISO and FDA regulations.• Medical devices from syringe design, IV Catheters, to Class 3 Disposable Jet Injectors and more advanced instruments including drug/device combinatory products.Regulatory Affairs (Biotechnology, Food, and Pharmaceuticals) Relevant Skills:• United States FDA: 21 CFR/eCFR 210/211 (Good Manufacturing Practices for Pharmaceuticals).• United States FDA: 21 CFR/eCFR Part 11• ISO 13485 and ISO 9001, and ICH/ISO guidelines • 510Ks and NDE/HDE/PMA submissions work• Class One to Class 3 Medical Devices development.• As a CAP/CLIA clinical scientist developed and validated over 20 novel clinical diagnostic assays and IVDs projects that are still used today; developed, validated, and transferred and managed over 250+ cGMP assay projects to CRO/CMOs, 250+ projects (CFDA Enzymes purified

www.pretred.com

https://magellanpharmaceuticals.com/

I performed all the duties and responsibilities expected of a QA Senior Director with minimal guidance other than being told what they wanted accomplished. Very Good Organization to Consult at.• GXP QA/Regulatory Affairs Project Manager (RA/PM) consultant for commercial validation projects• Regulatory compliance and quality director for lot-to-lot release of CMO products• Conducted and Completed a Major Virtual Audit for a new CRO

Develop Analytical Testing processes to accurately measure Cannabinoids directly from food products

My duties and responsibilities require a rare blend of Analytical Scientist, Project Manager (PMP), Regulatory Affairs, Compliance, and Quality Assurance/Quality Control (QA/QC)

Purification of Monoclonal and Polyclonal Antibodies along with other special Projects

Completed >250+ separate projects in 4.7 years utilizing Portfolio Project Management Institute (PMI) best practicesSaved the company over $200,000 to $250,000 minimum annually utilizing Lean Six Sigma Best Practices (>20% of annual budget) and a single AKTA Purifier. Involved from beginning to end.I was also responsible for all products freeze-drying, shipping to China, and writing all regulatory MSDS documentation as well.The business processes that I developed in the US was transferred to China resulting in development savings >$10 Million + during the scale up process.

OligoCo (formerly Blue Heron Biotechnology) my duties involve compliance with state and federal hazardous waste regulations, taking care of any regulatory and quality issues, writing regulatory documents, and setting up the company for ISO 2004 compliance.

A cGMP Senior Compliance professional with comprehensive experience in GMP regulated manufacturing. An inquisitive technical leader who delivers results and continuously improves GMP processes by owning them. Expertise and success in a GMP regulated environment: Facilitated and improved quality management systems: Investigation, root cause analysis, CAPA, deviation, training, auditing, audit tracking & response, report to management; data analysis and trending• Developed and performed risk assessment strategies (commercial gap assessment, investigations, supplier audits and portfolio project management)• Developed business practices for conducting self-assessments, project portfolio management, management communication, and reporting tools and Change ControlManagement Coordinator for manufacturing• Establishment of procedures for identifying training needs and evaluated suppliers, contractors, and consultants through the use of work practice documents based on SOPs• Reviewed and approved GMP documents, including SOPs, batch records and test methods, equipment validation protocols, and method transfer documents• Effectively supported QA/QC/RA/Research groups, aiding in overseeing data audits, processing deviations, non-conformances, and CAPAs• Weekly and Quarterly track and trend deviations, non-conformances, corrective actions, OOS, change controls, investigations and other metrics in support of management review• Tracked complaint activity for potential trends in complaint types or frequency and notifies management of significant complaint issues in timely manner utilizingMinitab Software and lean manufacturing processes• Establishing and implementation of quality policy, planning, and system procedures• Establishment of written procedures and execution of internal quality audits including re-audit of deficiencies• Regulatory support for first and third-party audits developing external audit records and corrective actions that were implemented.

This Company was acquired by Origene

This company was acquired by Amgen in 2002 and no longer exists in Seattle/Bothell Areas.Responsibilities included supervision and training of Senior Quality Control Associates, Quality Control Associates, Analysts and Support Staff for the day-to-day operation of QC testing (cGMP) of chemical and biochemical assays for raw materials, in-process samples, bulk drug substances and drug products utilizing LIMS, HPLC techniques-Amino Acid Analysis, Affinity, Reverse Phase, Normal Phase, Ion Exchange, Ion-Pairing, Protein A, Size Exclusion, Hydrophobic Interaction, Carbohydrate Analysis and Peptide Mapping with Agilent, Dionex and Waters HPLC Instrumentation and appropriate software packages. Writing and executing equipment validation protocols (IQ/OQ/PQ/MQ), method transfers (MT), method validations (MV) and final reports; writing, reviewing and modifying standard operating procedures (SOPs) and participated in the preparation and submission of NDAs, INDs, IND amendments and responses to inquiries from regulatory agencies. Provide project team representation from and direction in managing information from/to other departments including R&D, Manufacturing, Quality Assurance, Regulatory Affairs and Medical/Clinical and contract manufacturers with respect to protein manufacturing (cGMP).

Responsibilities included drug formulation of class IV small molecules, method development (cGMP) of chemical and biochemical assays for raw materials, in-process samples, bulk drug substances and drug products utilizing FTIR, NMR, GC/MS, LC/MS and HPLC techniques-Chiral, Gel Permeation, Reverse Phase, Normal Phase, Ion-Pairing and Mass Spectrometry with Agilent HPLC Instrumentation. Provide project team representation from and direction in managing information from/to contract manufacturers with respect to small molecule manufacturing (cGMP).

This company was acquired in 1998 and no longer exists in the Seattle area.Responsibilities included method development, Quality Control, supervision and training of Chemists and Support Staff for the day-to-day Seattle operation of clinical diagnostic testing (CLIA) of blood cells, plasma, saliva, serum, stools and urine utilizing Amino Acid, EIA, ELISA, Fluorescence, GC/MS, RIA, SDS-PAGE, SPE, Spectroscopy and HPLC techniques with Beckman, Hewlett Packard, and Waters Instrumentation and appropriate software packages; writing, reviewing and modifying standard operating procedures (SOPs). Developed over 25 novel clinical diagnostic tests at the Seattle Division and transferred to the Asheville Division of GSDL. Provide project team representation from and direction in method transfers (MT), method validations (MV) and final reports from/to Asheville Division with respect to clinical diagnostic testing (CLIA). Safety Officer for the Seattle Division of GSDL.

Responsibilities included method development; writing, reviewing and modifying standard operating procedures (SOPs); litigation cases in Montana involving groundwater contamination; fungicide, insecticide and pesticide testing of ground water, soil and vegetation utilizing CE, GC, GC/MS, SDS-Page, SPE, Spectroscopy and HPLC techniques with Beckman, Pickering, Hewlett Packard, Dionex and Waters Instrumentation and appropriate software packages.

Graduate Teaching Assistant and Graduate Research AssistantGraduate research emphasis on 3-D Molecular Modeling of G-coupled Protein Receptor SystemsRhodopsin interactions | Bacteriorhodopsin interactions | TNFR interactions | CD4 LigandsI produced 3-D Molecular Models of these proteins binding sites with peptide probes and utilizing a variety of 2-D nuclear magnetic spectroscopy (NMR) techniques, mass spectrometer (MS) techniques, X-ray crystallography data, and powerful Software utilizing state of the art Unix based Silicon Graphics workstations.

Journeyman level precision machinist