Patricia Squitiero

San Francisco Bay Area, California

https://www.linkedin.com/in/psquitiero adm8rx@r.postjobfree.com PROFESSIONAL SUMMARY

Experienced Regulatory and Research Compliance Subject Matter Expert with 3 years’ experience in project management in the software industry. I currently take a lead in representing iMedRIS virtually and at public events. My career started working in the research field using animal model systems to conduct experiments, then progressed into the research compliance realm. For the past 3 years, I have been working in the software industry providing feedback on User Experience, required regulatory updates and training staff and clients on how to use the software. Compliance

Biosafety

Human and Animal

Subject Research

Analytical Skills

UX/UI Consulting

Training

GLPs & GCPs

Genetic Analysis

Forensic Science

Toxicology

Customer Service

Post-Approval

Monitoring

Business Continuity

and Emergency Plan

Policy Drafting Animal

Husbandry

CAREER HIGHLIGHTS

Problem Solving

● Using subject matter expertise, scoped out changes to the workflow of the Post-Approval Monitoring software to better reflect real world situations.

● Re-designed the UX mockup and workflow changes required to encompass Human Subject Research regulatory requirements for both the FDA and OHRP Final Rule. Leadership

● Current Mentor for a competitive Intern program empower and facilitate awareness of the need for access to diabetes in BIPOC and underserved communities.

● Lead Public Relations Liaison to promote brand awareness for two software companies.

● Directly reports to the CEO and Director of Finance

● Created a standardization procedure/process for labs that allowed the number of labs to be increased from 22 to 48 in one school year.

● Created Cost Benefit Analysis and Day-to-Day Operations Budget to advocate for the hiring of a new employee.

● Designated as the Point Person to respond to surprise inspections from regulatory bodies. Research

● Actively contributed to research studies and co-authored a published scientific study. Compliance

● Developed plan for emergency continuation of animal management operations and successfully implemented this plan during a declared statewide weather emergency. PROFESSIONAL EXPERIENCE

iMedRIS & SaaberTech, Inc., Redlands, CA Regulatory Compliance Consultant & Project Implementation Specialist Feb 2020-present

● Lead Public Relations Liaison and Product Marketing acting as the “face of the organization” to promote brand awareness.

● Reports to directly to the CEO and Director of Finance

● Supervise and work with project managers to support project completion.

● Participate in cross-functional teams and effectively communicate difficult concepts at a high level, as well as the technical details, to various stakeholders within the organization.

● Act as the Voice of the Customer (VOC) and translate user needs provided by customers into software requirements for the Development team by soliciting, aligning, and incorporating feedback from diverse stakeholders.

● Provide feedback on product development per federal, state and local regulations governing Human and Animal Subject, Biological Research, DURC, Export Control and Controlled Substances to mitigate risk.

● Develop and write Standard Operating Procedures for software product. Squitiero Consulting LLC, Fremont, CA Strategic Consulting / Regulatory Compliance Consultant October 2018-present

● Provide strategic consulting of regulatory needs and business process improvements.

● Conduct onsite facility and laboratory inspections.

● Draft standard operating procedure (SOPs).

● Guide training needs to comply with biosafety and laboratory safety practices Key Solutions, Inc., Fremont, CA Regulatory Compliance Subject Matter Expert and Software Trainer March 2018-January 2020

● Senior level position with a direct report to the Vice President of Implementations.

● Acted as the Voice of the Customer (VOC) and translate user needs provided by Marketing and customers into software requirements for the Development team by soliciting, aligning, and incorporating feedback from diverse stakeholders.

● Lead the development of customer-facing documentation and training materials, e.g., user guides, training manuals, etc.

● Participated in cross-functional teams and effectively communicate difficult concepts at a high level, as well as the technical details, to various stakeholders within the organization.

● Worked with offshore team to understand technical requirements and communicate/collaborate with users to analyze customer needs and functional requirements.

● Provided feedback on product development per federal, state and local regulations governing Human and Animal Subject, Biological Research, DURC and Controlled Substances to mitigate risk.

● Worked with the Product Manager to develop User Stories and enhance the User Experience.

● Developed and wrote User Guides for the various software products. Midwestern University, Glendale, AZ Research Administrator November 2016-January 2018

● Assisted in ensuring that the Human Subjects Protection Program, Animal Protection Program and Animal Facility, as well as the Radiation Safety and Biosafety Committees have adequate resources for compliance to all relevant federal, state, local, and university regulations and policies; Worked with the ORSP Assistant Director in any situation where adequate resources are not available.

● Drafted and followed-up on the Semi-Annual Inspection reports, OLAW Annual Report, USDA Covered Species Annual Report and relevant permits for the Institutional Official.

● Assisted the ORSP Assistant Director and Director to maintain appropriate licenses, assurances, regulations, and guidelines to meet various requirements for NIH, NSF, OSHA, ARRA, OLAW, AAALAC, EPA, OHRP, etc.

● Assisted with development and implementation of the best service-oriented manner to incorporate compliance- related activities at MWU's Glendale campus.

● Performed an initial review of IRB and IACUC protocols to ensure compliance with IRB and IACUC regulations.

● Coordinated IACUC, IRB, Biosafety and Radiation Safety Meetings; organize meeting agendas; Wrote meeting minutes, send meeting requests, and prepared meeting documents.

● Organized, filed, and tracked new and annual review dates for all research protocols submitted to the IRB and IACUC.

● Tracked all training documentation for the IRB, IACUC, Biosafety, and Radiation Safety Committees. University of Massachusetts, Amherst, MA IACUC Program Coordinator I January 2015- October 2016

● Trained over 500 faculty, students and staff about IACUC regulations and working in the facilities.

● Served as Executive Secretary to the IACUC includes preparation of IACUC minutes.

● Tracked and adhered to strict deadlines of all protocol related activities.

● Scheduled and supported the IACUC for the conduct of federally mandated semi-annual inspections of animal use facilities and other animal research areas.

● Followed up with faculty and staff on results of Semi-annual Inspections per OLAW Guidelines.

● Facilitated the completion of Inter-Institutional Agreement forms.

● Troubleshoot electronic management software issues and act as a liaison for communicating software related issues.

● Supervised work-study/graduate student.

● In addition, all duties listed in the Compliance Assistant position (below). University of Massachusetts, Amherst, MA Compliance Assistant January 2014- January 2015

● Pre-reviewed IACUC (animal use) protocols for content and determine the need for course of action.

● Interpreted and organized reviewer comments and relayed them to the Principle Investigator (PI).

● Maintained a timeline of all protocol related activities and assign protocol review levels.

● Ensured all listed on animal use protocols have completed IACUC training.

● Coordinated with Environmental Health and Safety (EH&S) to ensure animal users also complete required EH&S training.

● Reconciled PI reports on animal numbers used against numbers approved on IACUC protocols to ensure usage does not exceed approved numbers.

● Maintained records of protocol annual renewals reminders sent to PI s and followed-up with PIs regarding expired protocols.

● Provided user support for e-Protocol and answer PI questions regarding status.

● Prepared materials for IACUC meetings.

● Participated in and documented on-site Post Approval Monitoring and Semi-annual Inspections. Westfield State University, Westfield, MA Administrative Assistant II June 2013- July 2013

● Demonstrated high levels of professionalism and service in communicating information to students and employers on Career Center services.

Westfield State University, Westfield, MA Laboratory Technician II June 2006- June 2013

● Voting member of WSU IACUC committee for 4.5 years.

● Interviewed, hired, supervised, and reviewed performance for 2 paraprofessionals and 6 work-study students; designed and implemented comprehensive training programs.

● Acted as a Resource Point Person over 300 students (per year) and 28 staff.

● Trained over 700 faculty, students and staff about IACUC regulations and Laboratory Safety and how to work safely in the facilities.

● Established and updated manuals for animal care

● Created and maintained inventory and chemical logs, and ordered supplies.

● Ensured compliance with state and federal regulations in interpreting and applying Good Laboratory Practices

(GLPs).

● Efficiently managed time and preparation for 48 labs; Created day-to-day operations budget.

● Prepared lab set-ups, cared for and maintained of vertebrates according to federal guidelines. USDA, Amherst, MA Administrative Assistant/Intern Soil Conservationist May 2004- July 2006

● Drafted correspondence letters and reports and responded to grant inquiries.

● Gathered and assembled preliminary data for use in developing and applying basic conservation plans.

● Worked on sustainability initiatives and assisted farmers with assessing agricultural and environmental problems in order to bridge the gap between optimizing farm productivity and maintaining environmental consciousness. RESEARCH EXPERIENCE

University of Massachusetts, Amherst, MA Research Fellow June 2005 - December 2007 Research Projects: Role of GABAA and Glycine on Spinal Cord Pattern Generators.

● Applied molecular biology and pharmacological techniques to assay GABAA and Glycine.

● Wrote manuals, trained, and instructed colleagues on laboratory methods.

● Ordered supplies, maintained general stock of solutions, and maintained databases. University of Massachusetts, Amherst, MA Student Researcher/Independent Study January 2000 -September 2006 Research Projects: Effects of Edema in Zebrafish & Bone as an Ion Exchange Organ in Mouse

● Used biophysics and cell physiology techniques for cell and ion investigations.

● Adapted techniques and taught my colleagues and students laboratory methods.

● Worked with fellow scientists from the Bone Unit Science Institute in Milan, Italy and travelled to Ludwig- Maximillian’s University in Munich, Germany.

● Coordinated efforts to obtain the mouse neonate and ordered supplies. PUBLICATIONS, PRESENTATIONS, MEDIA CITATIONS AND GRANTS

● Marenzana, M. Shipley, A.M., Squitiero, P., Kunkel, J.G., Rubinacci, A. Bone as an ion exchange organ: evidence for instantaneous cell-dependent calcium efflux from bone not due to resorption. Bone. 2005 Oct; 37(4):545-54.

● Poster presentation, Bay Path University, April 2015: Recovery of degraded DNA from detonated incendiary devices (Molotov cocktails) to generate STR profiles for admissibility as evidence.

● Poster presentation Massachusetts State 10th Annual Undergraduate Conference, May 2004: Edema In Zebrafish Causes Cell Pathway Disruption And Inhibition Of Jaw And Gill Formation.

● Poster presentation Massachusetts State 10th Annual Undergraduate Conference, May 2003: Cellular Effects of Edema in Zebrafish.

● Students’ “High-Stakes Science Eye Aberdeen Water Pollutant.” The Baltimore Sun Dec. 2002.

● Recipient of Woods Hole Travel Grant, Awarded through UMass-Amherst in 2003 (project conducted in Ludwig Maximillian’s University, Munich, Germany)

● Recipient of Bio-Med Collaborative – Baystate Medical Center Research Grant, UMass-Amherst 2002 MEMBERSHIPS AND COMMUNITY ENGAGEMENTS

● Voting Member California State Bar Association Closing the Justice Gap Working Group, 2020-present

● Voting Member American Association for Laboratory Animal Science, 2011, 2015 to present

● Member Public Responsibility in Medicine and Research (PRIM&R), 2014 to present

● Member Hispanic Chamber of Commerce San Jose and San Francisco Branches 2021 to present

● Member and Mentor BioCurious/ OpenInsuling.org 2020 to present

● Voting Member of (URC) University Research Committee, Midwestern University, 2017-2018

● Voting Member of Institutional Animal Care and Use Committee, Westfield State University, 2008-2013

● Voting Member of (CIP) Committee on International Programs, Westfield State University, 2013

● Voting Member of Sankofa Diversity Committee & Scholarship Committee, Westfield State University, 2009- 2013

● Committee member (NEASC) New England Associations of Schools and Colleges Task Force (assisted and devised Public Disclosure and Integrity portions) Westfield State University, 2012

● Amherst Hurricane Boosters Sports Fundraising Committee, 2013 EDUCATION

Masters of Science in Forensic Science (incomplete - 32/36 credits), Bay Path University, Longmeadow, MA 2014-2016 Forensic M.S. Capstone Topic: Recovery of degraded DNA from detonated incendiary devices (Molotov cocktails) to generate STR profiles for admissibility as evidence. Bachelors of Science in Biology, University of Massachusetts, Amherst, MA 2004 LABORATORY SKILLS

Molecular Biology & Genetic Analysis

Topo Cloning

Construction

morpholinos

Human DNA Short

Tandem Repeat

Genetic analysis

Created primer pairs

RT-pCR

DIG Labeling

Mouse and Transgenic

Fish Husbandry

Epifluorescence

Microscopy

Immunoblotting

Electropherogram

interpretations of

Human STR DNA

(beginner level)

Toxicology & Drug Analysis

Gas Chromatography and Mass

Spectrometry

Tunnel and Radio Immunoassay

Fine/ Surgical Techniques and Other Techniques

Plasma extraction pericardial of Zebrafish

Surgical removal of metatarsal mouse bone

then drilled a 100-mum hole in time

sensitive procedures

Surgical removal of heart and brain then

sliced and stained rat brains

Scanning Electron Microscopy: fixation,

sputter coating, sectioning and mounting

COMPUTER SKILLS

Camtasia

Word Press

Microsoft Office

Support Suite

Easy Red Mine

Smartsheet

Trello

Zoom

Adobe Illustrator

Acrobat Pro

Primer-BLAST

GIMP

Mac Vector

Image J & tpsDiG

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