Stacey Johnson - Pharmaceutical Quality Compliance Professional,

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Work Background

i-Pharm ConsultingQuality Consultant

Oct. 2022United States

Vertex PharmaceuticalsSr. Quality Manager, External Operations

Jul. 2021 - Nov. 2022

Tom's of MaineQuality Compliance Supervisor

Aug. 2016 - Jul. 2021

PfizerManager/Team Lead, Quality Operations

Sep. 2013 - May. 2016Pearl River, NY• Review and approve Customer Complaint and Manufacturing / Lab Deviation Investigation reports ensuring appropriate Root Cause analysis and CAPA identification/implementation • Manage 10 direct reports to establish and maintain a comprehensive shop floor Quality Oversight program to support the 24-7 production schedule • Aseptic SME and escort for Global Regulatory Auditors for sterile injectible production facilities • Maintain Defect Library for products in syringe and vial presentations to align defect terminology throughout product network, document and classify new defects • Audit aseptic and supporting areas for housekeeping, compliance and inspection readiness; provide feedback to auditee areas; and review/approve responses  Designed and procured VP level approval of Aseptic Auditor Training Program for Corporate Auditing Group, incuding 6 hours of classroom training, video review and exams as the first of four steps to auditor training completion  Designed and performed training of Back to Basics topics (GMP documentation requirements, gowning, aseptic practices, etc.) for 178 shop floor personnel upon return from semi-annual shut downs in January and August

PfizerAseptic Compliance Lead for the Aseptic Performance Team (Quality Control)

Feb. 2012 - Sep. 2013Pearl River, NYThe Aseptic Performance Team (APT) was created to respond proactively to increased regulatory scrutiny of aseptic practices and clean room behavior in the Biotech and Pharmaceutical Industries, and I was appointed the Aseptic Compliance Lead for the team. The responsibilities of this new position included: • Review environmental monitoring deviation investigations for aseptic compliance issues and assist in determining corrective actions • Identify / implement new processes and procedures to reduce and control contamination, including training and education programs, metrics, etc • Participate in Pfizer Inc Network Team regarding aligning changeover activities throughout all aseptic sites driven by the Pearl River Site Production Lead • Write / review training materials to create a Pfizer Inc Network Aseptic Training Program for consistency throughout the aseptic sites • Identify / implement new processes site-wide regarding contamination control, currently a new cleaning program that will provide better cleaning of facility surfaces at a reduced cost • Coach / mentor new Aseptic Processing Team members on regulatory, corporate and site requirements regarding contamination control processes and procedures  Implemented new facility cleaning method and equipment which reduced microbial recovery by 39% and average cleaning time by 30 minutes, and saved Pfizer $500,000 annually  Created 4 Step Replication Package for implementation of cleaning method at all Pfizer sites globally

Pfizer (formerly Wyeth)Sr. Operations Compliance Specialist

Apr. 2008 - Feb. 2012Pearl River, NY• Conduct audits of aseptic practices for internal areas and also for emerging market sites internationally to ensure adherence to GMPs as well as appropriate aseptic technique and clean room behavior • Facilitate audits of Syringe and Vial Filling, Inspection, Packaging and Component Preparation areas for regulatory, corporate and internal personnel, and prepare, submit and implement responses to any observations • Perform detailed research and evaluation to identify risks of new practices and author Quality Risk Assessment documents to support improvements in established production practices • Work with area management to maintain compliance with all regulatory (international and domestic) requirements, including providing interpretation of regulations and identifying gaps in current processes and procedures  Implemented “Aseptic Tip of the Day” program which was adopted for use at all Pfizer Inc. Aseptic Sites globally to drive correct aseptic behavior

WyethManufacturing Systems Specialist

Apr. 2007 - Apr. 2008Pearl River, NY• Revised / updated Standard Operating Procedures (SOPs) and Skill Assessments as related to new projects, facility or equipment changes • Implemented / directed training for the Aseptic Facility Cleaning Program which included training and certifying operations personnel as Aseptic Processing Area (APA) cleaners • Investigated, analyzed and troubleshot manufacturing gaps and developed plans for updating the GMP Systems Manual • Maintained area metrics and KPIs, provided monthly reports for upper management oversight  Implemented Job Aid for responses to Disruptions to Controlled Environments to drive consistency throughout all manufacturing areas on the Pearl River site, which was adopted by the Corporate Microbiological Aseptic Services group for introduction across the Global Pfizer Network

WyethSr. Training Specialist, Aseptic Training Initiative

Jun. 2005 - Apr. 2007Pearl River, NY• As Master Trainer, trained employees on aseptic techniques and contamination control topics including Clean Room protocol and Disinfection Practices • Created / implemented check lists for training, coaching and auditing purposes; transitioned Competency Checklist documents into Skill Assessments and Audit Check lists • Mentored new department trainers; consulted with Wyeth Vaccines Department Trainers and collaborated with the Technical Training Manager on methods for improving Vaccine Department trainer skills  Implemented Job Aids for auditing of aseptic practices, environmental monitoring, facility cleaning and gowning practices to provide shop floor supervisors and managers with a reference against which they could measure their personnel’s activities

WyethTraining Specialist, Drug Substance

Jun. 2002 - Jun. 2005Pearl River, NY• Facilitated Training; reviewed and corrected all training curricula and any missing components • Participated as a founding member and Secretary of the Vaccines Training Committee created to drive consistent training requirements across the Pearl River site • Served as a team Member of the FLEX Operational Excellence team to streamline work processes  Increased overall departmental training completion percentage from 35% to 97% during first six months in position

Various - Prior Employment ExperienceVarious

May. 1990 - Jun. 2002VariousAfter graduating college, accepted a position as a Legal Assistant with the law offices of Samuel Starks, Stamford, CT (05/90-09/97) where I managed accounts receivables and payables and met with clients to assist in various issues. Thereafter, relocated to Boston, MA where I served as a Substitute Teacher in the Boston Public Schools (09/97-06/98) and concurrently worked with Barnes & Noble Booksellers, Chestnut Hill, MA as a Department Manager (12/97-11/99). I left Barnes & Nobel to take a position at Brandeis University as a Student Loans and Collections Administrator (11/99-03/01). I relocated to New York in 2001, where I was the Perkins Loan Coordinator at Marymount College, Tarrytown, NY (03/01-06/02).