Remote Data Entry Analyst

B. (Bambi) Layne Corrigan

**************@*****.*** +1-617-***-**** cell +1-213-***-**** office https://www.linkedin.com/in/bambi-layne-8aa8657/

Global pharmaceutical, biotech research, quality, and validation professional experienced in cGMP/GLP and ISO environments. Partnered and cross-trained in multiple operational disciplines including but not limited to QC/QA, laboratory equipment validation, raw material sampling, micro-biology, and water sampling. I specialize in technical writing for customized validation protocols, SOPs, qualification plans, site plans, risk assessments, and ICH guidelines. Pharmaceutical/manufacturing quality systems, including GxP, CAPAs, QMS change control, deviations/non- conformances, documentation, audit preparations, cGMP training, risk, and gap analysis. Quality validation, protocol preparation, and execution as per client specifications and CMC support. Validation of electronic notebook compliance regulations as pertaining to 21CFR Part 11: electronic records and electronic signatures and Annex 11-Computerized Systems; 21CFR Parts 210/211-GMP. EMA-EU GMP, and ICH Q7-API manufacturing; 21CFR Part 820-Quality Systems and ICH Q10-Pharmaceutical Quality System; software development cycle guidelines ASTM E2500-07, compendia guidance USP Analytical Instrument Qualification<1058> and European Pharmacopoeia standards, and ISO standards 9000, 13485 and 14971-medical devices, 17025-metrology. Instrumentation limits and usage capability specifically enforceable during validation schedules and audits. Current computer applications and platforms; Proprietary GLP LabManagement software (eQMS), BlueMountain, TrackWise, Smart Solve (IQVIA/Pilgrim), Sample Manager, LIMS, Veeva, MasterControl, Empower, SAP, LabWare, MicroSoft Sharepoint, SmartSheet, Box, Lucid Charts, Miro, Excel, Word proficiencies PROFESSIONAL EXPERIENCE

sciLayne January 2020 - current

Founding Scientist - Private StartUp

Research and Development MedTech Company for:

- sweat sensing technology detecting thyroid stimulating hormone (TSH)

- YÖM (your optimized metabolism) thyroid wearable for real-time diagnostics and variably daily dosing based on metabolic need integrated with syncT, healthcare integrated communications

- DentX DDS, the more comfortable and practical digital dental Xray NSF Grant Phase 1 Invitee for thyroid diagnostics

Commercial Services: Quality Compliance and Technical Writing solutions, your holistic and practical GxP solutions from clinical to commercial

- BLA updates; Supplier comparability reports

- AQR/PQR annual reports

- Stability Reports

- Method Validation Reports

- Validation Protocols; Equipment Testing, EM Testing, Analytical Methods

- Policies, SOPs

- Quality Manuals and Quality Plans

- Specification templates (MSPECS)

- Data Trending

- CAPA, Deviations, Change Control Management

- Investigations

- Gap and Risk Analysis

- PHI

Denali Therapeutics December 2022 - December 2024 Quality Systems Technical Writer Consultant via Bayside Solutions QMS Technical writing for GxP QMS supporting all departments for South San Francisco and Salt Lake City cGMP readiness through change control and CAPA support.

Document initiation and eDMS routing for approval and implementation. KPI Quality tracking

LFB-USA Framingham, MA November 2020 - August 2022 August 2022 - December 2022 Quality Systems Scientist FTE Quality System Scientist Consultant Quality Systems Management lead

Global regulatory support for Quality Control

Authored supplier comparability technical reports for product BLA update Participated in authoring AQM reports

Responsible for timely closure of new quality system exceptions, legacy projects and long term remediation exceptions. Responsible for applying current practices for QC/QA exception documentation and reporting. Conduct technical and quality investigations in collaboration with QC laboratory personnel and management. Authored deviation investigation, corrective action and change control reports according to LFB policies and procedures. Work cross-departmentally with QA and other functional groups to collaborate and author quality system exception documentation.

Document life cycle including submission and review of new and existing documents via eDMS LFB-USA Framingham, MA January 2020 – November 2020 QC Technical Writer and QMS Support – Contract via Black Diamond Network QMS Support

QMS project lead for legacy CAPA Change Control Deviations OOS investigations closures Sensitech Beverly, MA March 2017 – August 2018

Document Control – Contract via Complete Staffing Solutions QMS Support; document and change control

Technical writing updating BOMs

QMS document site integration

NC Finances Inc. & Ltd. Culver City, CA & London, UK December 2012 - December 2014 Sustainability Manager - Private Start Up

Managed quality system of humanitarian project submissions, proposals and contracts for financial aid packages Edited and presented new financial and development projects to governmental ministries for socio-economic well-being of populations through improved infrastructure, health, education, and fair trade practices Contract Management Sovereign Guarantee financial platforms for integration to Governmental Development Plans incorporating local sustainable efforts within the business plan Editor and Group Presenter: Comprehensive National Development proposal: Ministry of Tunisia. Presented 2014 Editor and Group Presenter: Comprehensive National Development proposal: Ministry of Cameroon. Presented 2014 Proposal Editor: Comprehensive National Development proposal: Ministry of Equatorial Guinea & Ghana 2014 LabMetrix Technologies Roissy, France & Irvine, CA October 2003-December 2011 Validation Engineer/Project Manager/Business Development – Independent Contractor Now a Perkin Elmer Company

IQ/OQ/PQ-PV validation execution for varying laboratory equipment following client SOP’s and infrastructure in cGLP/cGMP facilities

Specialty in customized protocols and specifications per equipment type meeting client’s requirements Project Management to onsite engineering teams for laboratory validations SME to customized Validation protocols for laboratory validation master plans Identified gaps in client operator usage versus instrument limits, specification, and uncertainty Non-compliance reporting to clients for immediate initiation of OOS and CAPA within client system and internal LabMetrix QMS

Asset management concerning laboratory equipment validation master plans Trained new validation teams in IQ/OQ/PQ-PV execution across multiple laboratory instrumentation disciplines in cGLP and cGMP environments, under 21CFR11and 820-quality compliance with certified metrology ISO 17025-certification Global laboratory sales and validation engineer training during the integration of LabMetrix Technologies to Perkin Elmer Equipment lists per confidential client contracts

GelTex Pharmaceuticals Waltham, MA March 2001 – August 2003 Quality Control Chemist II - FTE

Now a Sanofi-Genzyme Company

Provided ongoing quality control analysis supporting micro-polymer small molecule phosphate and cholesterol binding ingestible therapy for Renagel and Cholestagel via HPLC, GC, UV/Vis, IR TLC, titrations, and physical appearance testing, for raw material, in-process, final product and stability dynamic analytical data, in a cGMP/cGLP, 21 CFR 11, compliant laboratory environment

Maintained laboratory instrument calibrations and validations schedule: IQ/OQ/PQ-PV Validation deliverables such as Validation Master Plans, qualification reports, test plans and SOPs Quality control analysis; raw material, in process, finished product and stability studies Advancement of GC method validations and technology transfer Direct analytical support for regulatory submissions and regulatory review Initiated investigations for OOS and CAPA instances Provided support of current procedures and document revisions and change control DuPont Pharmaceuticals Medical Imagery Billerica, MA March 2000 – March 2001 Research Analyst – Contract via ProSource Inc Waltham, MA Now a Bristol Myers Squibb Company

With researcher Dr. Shuang Liu PhD, purification and lyophilization of cancer therapy small molecules Radio-labeled molecules for therapeutic and imaging agents in animal studies Research under cGLP environment

Protocol advancement in HPLC purifications for clinical trial prep and subsequent quality control environments Direct research and quality support for drug discovery and development Occidental Chemical Grand Island, New York January 1998 - January 2000 Chemical Analyst and MSDS Coordinator – Contract via ManPower Now Isle Chem LLC

Durez Division preparation of proprietary emulsion analysis MSDS Coordinator

CMC Analytical support for ICP-AES; plant operations and pharma pilot plant scale up Holtra Chemical Wilmington, North Carolina September 1999 Chemical Analyst - Consultant

Optimization of ICP methods of standard addition for plant analysis and product release CAPA brine contamination of analytical lab

Laboratory environment was decontaminated of residual brine implementing entry procedures by need only to reduce excess brine contamination for accurate analysis

Westwood Squibb Buffalo, NY November 1996- 1998

A Bristol Myers Company (now closed)

Quality Control Analyst

CMC Support for in process dermatological and beauty products HPLC, pH, Uv-Vis, FTIR, LOD, Micro, Raw Material Sampling, Environmental Monitoring, and stability program support B. Layne Creations Eco-Transformations Inc. November 1999 - Current A wholly owned subsidiary of B. Layne LLC - Buffalo, Paris, Brookline, Culver City, Providence Founder; Sustainable Design; up-cycling, redesigning, recycling and reuse Eco-Transformations. Published September 2014; under Bambi Layne Njamfa. California Green Press. Authored a 300 DIY page workbook for fashion and homeware sustainability Guest speaker: Sustainable Design: KenTon Harkness April 2016 Guest speaker: Sustainable Design: Occidental College April 2016 Guest speaker: Re-use and Recycling; Santa Monica College September 2015 Exhibitor: GreenFest LA 2015 Eco-Transformations Book Launch Exhibitor: GreenFest LA 2013 Eco-Transformations Book Concept Launch EDUCATION

D’Youville College Biology B.A. Minor History

Buffalo, New York 1990-1995, 2018-2019

Student-Conceived Project Research: Detection of Thyroid Stimulating Hormone (TSH) in sweat (hydrosis) by SPE LC-MS

D’Youville College Chemistry Club

Harvard Extension School

Sustainability and Environmental Management

Cambridge, MA 2005, 2007, 2008, 2011, 2019

Bonaire Expedition; Health of the Caribbean coral reefs and ecosystems 2008 Niagara County Community College

A. A. S. Science Laboratory Technology

Sanborn, New York 1989-1990, 1994-1995

Science Professionals Association

Editor to The Spirit – NCCC’s only school newspaper CERTIFICATIONS / PROFESSIONAL AFFILIATIONS

International Institute Model U.N. for D’Youville College– Rapporteur, Economics and Finance Subcommittee March 2019 Private Pilot Ground School: Beverly Flight School, Beverly, MA Spring 2018 American Sailing Association: Basic Keel Boats and Coastal Cruising; Blue Water Sailing - Marina del Rey, CA; March 2015 National Association of Professional Women: Los Angeles Chapter 2014 Alliance Francaise Delft A1; Fluent French: Technical reading and writing; April 2011 French Work VISA: Titre de Sejour; No: 15M5B692E Expiration Date; 06/26/2022 PADI Scuba Certified 1999, Recreational Diver; Lake Erie, Bonaire, Maldives, Bahamas Institute of American Chemical Engineers: Pilot Plants Certification; Grand Island, NY; 1998 COMMUNITY / VOLUNTEERING

PANMASS Challenge 2017: Rider, Wellesley to Provincetown 2017 Oktoberfest 5K Volunteer John R Oishei’s Children’s Hospital 2016 Oliver’s Restaurant- Buffalo, New York - Event Floor Supervisor; Annual Gala’s 2016 Earth Watch Institute Coral Reef Management and Fish Survey; Cape Eleuthera Institute March & August 2015 Baldwin Hills Community Action Plan Committee-La Brea Oil Field Assessment: Culver City, CA 2013, 2014, 2015, and 2016 Cycle America Summer 2007: Coast to Coast: Corporate Sponsor: LabMetrix Group; Leukemia Association

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