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Click here or scroll down to respond to this candidateCandidate's Name
Grayslake, IL Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLELINKEDIN LINK AVAILABLESKILLS: Wrote NDA Submissions Project Management SOP Development IOQ/PQ Protocol & ReportWriting cGXP Continuous Improvement Regulatory Affairs CAPA Writing, Reviewing andApproving Utilized Change Control Supported FDA Audits Non-Conformances Sterilization Development MedDevices/IV Solutions Customer Complaints Training/Compliance Sterile Injectables Fundraising Medical Publishing Fully trained a new employeeremotely. Auditing Data IntegrityPROFESSIONAL EXPERIENCE:Fundraising SpecialistSelf-EmployedOctober 2023 Present Raised over $10K for a new headquarters for a non-profit organization in Rubio, Venezuela and collaborated with the Executive Director in successfully implementing a dollar-for-dollar match which exceeded the $10K goal by 25%. Worked with a private 501c3 organization on a capital campaign and successfully raised $50K towards the purchase of property and the construction of new K-12 school in Kenosha, WI Currently creating two (2) fundraising brochures which will be used as tools to raise awareness to potential 501c3 donors. Designing a brochure informing employees and retirees on how to tap into their companys matching gift programs and a brochure educating potential retired donors how to tap into their IRAs to make tax-free donations to qualified charitable organizations. Viant Medical, Wheeling, ILQA Validation Engineer (Short-Term Consultant)June 2023 July 2023 Supported passivation process for onboarding a new piece of equipment. Collaborated closely with the vendor to assure that all user and functional requirements were met. Created IOQ, PQ and Safety Work Instruction documents. Created and reviewed SOPsResearch Products International (RPI), Mundelein, IL QA Validation Engineer (Short-Term Consultant)January 2023 February 2023 Supported cleaning validations. Created IOQ and PQ documents. Reviewed software validation documentation. Created and reviewed SOPsCatalent Pharma Solutions, Morrisville, NCQA Validation Engineer (Consultant)July 2021 November 2022 Supported validation team on equipment qualifications and change requests as QA Validation approver. Ensured all process, material and procedural changes are sound and in compliance with all regulatory requirements. Interfaced with Engineering and Operations to ensure transfer to Production of new products. Collaborated with customers and internal teams to achieve quality deliverables. Audited a variety of manufacturing processes and dosage forms at various stages of pharmaceutical development. Evaluated processes and ensured capability and proper documentation and training exists based on product requirements. Represented the Quality Department in Change Control activities associated with manufacturing equipment and processes, Nemera, Buffalo Grove, ILQuality Engineer (Consultant)January 2020 August 2020 Prepared pFMEAs, validation protocols, design control documents and summary reports Created SOPs and work instructions for sterile injectable combination devices. Developed Master Plans and implemented program-specific risk-based compliance strategies. Worked with third party suppliers in support of new product development including design control changes. Abbott Laboratories, Abbott Park, ILValidation Engineer (Consultant)March 2018 January 2020 Supported remediation efforts for facilities, utilities, and equipment validation packages. Conducted periodic reviews and gap assessments using TrackWise. Reviewed trend data, statistical rationale, quality requirements, non-conformances, and validation deliverables. Created cross-functional teams to review feedback from several functional areas. FMI Medical, Lincolnshire, ILQuality Engineer (Consultant)October 2017 - November 2017 Created procedures and associated forms for receiving new materials. Created cleaning and monitoring procedures for a new Class 7 cleanroom. Prepared cGDP and cGMP PowerPoint training modules for new employees Merz North America, Franksville, WIValidation Consultant (Consultant)July 2017 - September 2017 Wrote, reviewed, and approved validation documents including protocols, reports process validations and created product specific manufacturing process flow charts.Regulatory Compliance & Associates, Pleasant Prairie, WI Quality Compliance Specialist (Consultant)January 2017 - May 2017 Remediated FDA 483s for a large drug compounding company Reviewed training, test method transfers, validations, SOPs, and non-conformance issues. Vesta Lubrizol Inc., Franklin, WISterility Assurance Quality EngineerJan 2016 - Nov 2016 Created procedures, protocols, and work instructions for dry-heat sterilization processes. Validated dry heat sterilization process for medical devices. Ensured viable and non-viable testing requirements for a Class 7 clean room. Supported the regulatory submission process for medical devices. Worked with ISO 13485, FDA 21CFR Part 820, and FDA QSR requirements. AbbVie, Abbott Park, ILCompliance Manager Medical Publishing (Contract Position) Aug 2014 - Dec 2015 Reviewed audited and approved manuscripts, abstracts, posters, and oral presentations for compliance prior to their submission to medical journals and congresses. Collaborated closely with Medical Writers and Publication Managers to assure compliance. Used computer-based technologies to track publications (Datavision) Trigon International, Aurora, ILQuality Assurance EngineerFeb 2013 - Aug 2014 Managed the CAPA program including training, reviewing, and approving. Worked with components used to create various orthopedic medical devices for Zimmer Biomet. Developed and performed individual and group training. Responsible for compliance to ISO 13485, 14971, and FDA 21CFR Part 820 Reviewed product and process non-conformances, design control changes and recommended remedial actions. Managed supplier performance and conducted internal and external audits. Beutlich Pharmaceuticals, Waukegan, ILManager Regulatory Affairs (Contract Position)Aug 2012 - Nov 2012 Assured regulatory compliance and managed the product registration process. Prepared regulatory opinions and proofread labeling and text descriptions. Cardinal Health Waukegan, ILSoftware QA AdvisorJul 2010 - May 2012 Ensured regulatory compliance and Part 11 requirements for validated systems. Led software validation and verification processes for several products and systems. Executed product labeling software test scripts and authored SDLC documents. Abbott Laboratories North Chicago, ILQuality Assurance Group Leader/Section ManagerJan 2005 - Oct 2009 Conducted annual cGMP and validation process training to audiences of up to 150 colleagues. Reviewed and approved both change and design controls. Assured validation and verification compliance with quality and regulatory guidelines. Managed equipment, facilities, utilities, and software Validation Review Boards Managed and reviewed both cleaning validation and verification initiatives. Reviewed and approved validation software development life cycle documents Served as QA SME on a 2-year project creating new policies, processes, and procedures. Led process improvement initiative resulting in a 50% reduction in validation documentation review time. Abbott Laboratories North Chicago, ILSenior Quality Assurance Validation EngineerDec 2001 - Jan 2005 Reviewed and approved equipment, facilities, utilities, and software documentation Developed and wrote standard operating procedures and summary reports. Assured validation documentation compliance with cGMP and quality guidelines. Conducted GLP/GMP risk assessments and safety training. Abbott Laboratories North Chicago, ILQuality Assurance Engineer (Contract)Jun 2000 - Dec 2001 Reviewed and approved validation documents for remediation compliance in response to an FDA Consent Decree Designed quality assurance training modules and participated on cross functional teams. Baxter Healthcare, Round Lake, ILResearch Associate and Research Assistant1980 - 2000 Ensured the integrity and compliance of data according to Standard Operating Procedures and FDA-regulated requirements. Worked on project teams to complete the technical assessment of several types of container systems. Analyzed both microbiological and engineering data to ensure successful product tech transfers for the container systems. Ensured primary container designs met functional and user requirements. Provided technical support to ensure timely resolution of any identified container issues to ensure successful tech transfers. Managed successful product tech transfers for parenteral container systems to manufacturing sites. Conducted static microbial ingress testing on many parenteral container designs and configurations. Prepared the sterilization sections for NDA new product submissions. Wrote new product development protocols and reports for both medical devices and parenteral solution containers. Served as the department Safety Coordinator for twelve (12) years overseeing a department of ninety. Collaborated with multi-disciplined functions as a project manager and team lead. Managed, scheduled, and participated in technology transfers to manufacturing facilities. Developed ethylene oxide sterilization and terminal steam cycles for medical devices and IV solution containers. Performed sterility testing, aseptic transfers, bioburden testing and static microbial ingress testing. Manufactured and evaluated biological indicators for resistance (for both medical devices and parenteral containers) Followed 21CFR Parts 210 and 211 during aseptic manufacturing. EDUCATION/LICENSESNational Louis University, Evanston, IL Bachelors Degree BA Management College of Lake County Grayslake, IL Associate Degree -AS General Studies Licensed State of Illinois Substitute TeacherTECHNOLOGIES:Microsoft Office, Track Wise and Datavision |
