Robin Arsenault Emrick
Principal Consultant @Emrick & Associates, Llc
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WORK HISTORY
Principal Consultant @Emrick & Associates, Llc
Boston, MA, US
Providing experienced validation support and guidance to FDA-regulated industries to achieve and maintain compliance, including: 2023-present: South Boston & Braintree, MA: Implemented risk-based CIP & COP cleaning programs, segregation practices in storage, inspection, and manufacturing areas. Updated procedures for critical cleaning; implemented hands-on personnel training programs [swabbing & visual inspection OJTs] and periodic monitoring. Assigned facility sanitization locations & intervals; supported environmental monitoring program updates and EMPQ testing.2022-23: Boston (Mattapan), MA: Wrote client’s first Cleaning Validation Policy to define a robust cleaning strategy; restructured CVMP to a risk-based approach; defined new product introduction, equipment characterization and visual inspection, and swab sample collection; tailored and delivered hands-on trainings.2021: Frederick & Boulder, CO: Restructured Cleaning Validation program while serving as Cleaning Optimization Lead at a biologics CMO specialized in oligonucleotide production. Led team on cleaning risk assessments, worst case soil rankings, sample collection (swabbing), and MACO calculations.2020: Rocky Mount, NC: Responsible for IQ, OQ & IQ/OQ qualifications for three Getinge Parts Washers.20••••19: Augusta, GA: Designed & implemented a manual cleaning validation program for medical device equipment for which there had never been validated cleaning. Prepared and shared site-wide training, tailored per team functions, to ensure adoption and maintenance of first-time validated cleaning program. These included performance of visual inspection, aseptic technique, swab collection and handling, worst case sample location identification, cleaning method development and execution checklists.20••••18: Elkton, MD: Vascular access medical device technology transfer and DHF remediation sustaining projects: V&V, IFU, Clinical Flow, temperature mapping, IQOQApplying for WBENC certification.
EDUCATION
University of New Hampshire
Bachelor's Degree, Biochemistry
University of New Hampshire
M.S. candidate (30/30 credits), Microbiology
SKILLS
ABOUT ROBIN ARSENAULT EMRICK
Bio/pharma and medical device professional with extensive cGMP experience in validation (packaging, cleaning, equipment and utilities, etc.); vaccine manufacturing; calibrations/metrology management; design history file (DHF) assembly and maintenance; and environmental monitoring. Teacher and speaker with international experience on Cleaning Risk Assessment and Validation Master Planning. 7 years supporting Medical Device clients on various projects, including while under consent decree, gives me insight into this industry\'s needs and priorities, particularly during capital expansions and technology transfers, and of course, assembling and maintaining a cohesive DHF to tell the story of the work.8 years of Validation in \'Big Pharma\' gave me daily experience with automated CIP/COP, plus SIP and CTU qualifications, along with a team approach to deviation/discrepancy investigations, root cause analyses and CAPA recommendations/resolution.10 years of Validation in contract pharmaceutical packaging environments with Unionized personnel meant serving many customers\' and departments\' needs by simultaneously juggling capacity and competing priorities without compromising Quality.Specialties: Cleaning Validation CIP/COP, Risk Assessment and Management, Compressed air systems validation, Equipment CQV and Process Validation, Calibration Program Management, Environmental Monitoring, Temperature Mapping, Potable and USP water testing, Design History File (DHF) compilation and Technology Transfers.
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