K G
@kg0
Quality Assurance Specialist with expertise in compliance and regulatory affairs.
What I'm looking for
I am a dedicated Quality Assurance Specialist with extensive experience in maintaining compliance and quality systems within highly regulated environments. My career spans various roles where I have successfully managed eQMS systems, developed training programs, and supported regulatory filings. I thrive in fast-paced settings, utilizing my problem-solving skills to identify compliance gaps and implement effective solutions.
Throughout my career, I have demonstrated my ability to build strong relationships with major accounts and collaborate effectively with regulatory agencies such as the FDA. My technical writing skills have allowed me to create and revise critical procedures and protocols, ensuring that all documentation meets the highest standards. I am passionate about promoting quality improvements and fostering a culture of compliance within organizations.
Experience
Work history, roles, and key accomplishments
Sr. IT Systems Lead
ProKidney Inc
Jan 2025 - Present (4 months)
Maintained the eQMS system and provided companywide training. Authored technical procedures, assisted with execution of procedures, and managed qualification/validation protocols and summary reports for IQ/OQ/PQ.
Quality Assurance Specialist III
ProKidney Inc
Jan 2022 - Jan 2025 (3 years)
Maintained the eQMS system and provided companywide training. Authored technical procedures, assisted with execution of procedures, and managed qualification/validation protocols and summary reports for IQ/OQ/PQ.
MasterControl System Administrator
dōTERRA
Jan 2022 - Jan 2022 (0 months)
Reconfigured and maintained the eQMS, initiated and managed quality events, and performed validations. Provided trainings, created and revised procedures, and supported daily operational needs and large projects.
Quality Systems Manager
Castle Creek Biosciences
Jan 2021 - Jan 2022 (1 year)
Oversaw the Document Control and Quality Systems department, maintaining the eDMS system and providing companywide training. Authored technical procedures, assisted with execution of procedures, and managed qualification/validation protocols and summary reports for IQ/OQ/PQ.
Quality Systems Specialist
Castle Creek Biosciences
Jan 2021 - Jan 2021 (0 months)
Led the implementation of an eDMS to limit paper usage. Authored technical procedures, assisted with execution of procedures, and managed qualification/validation protocols and summary reports for IQ/OQ/PQ.
Quality Specialist
Blood Bank of Delmarva, d.b.a New York Blood Center
Jan 2020 - Jan 2021 (1 year)
Ensured the quality and safety of donors and products, collaborating with the Director of Testing Laboratory to ensure compliance with regulatory agencies. Participated in the implementation of quality management systems and process improvements.
Document Control Specialist
Blood Bank of Delmarva, Inc.
Jan 2019 - Jan 2020 (1 year)
Served as a subject matter expert for eDMS and implemented modules, including deviations and CAPAs. Collaborated with NYBC enterprise and suppliers, organized and filed critical department procedures, and managed supplier qualifications, licenses, and permits.
Quality Control Sample and Document Coordinator
Spark Therapeutics
Jan 2018 - Jan 2019 (1 year)
Managed samples and associated documents for QC Laboratories, including shipping to contract organizations. Coordinated in-house testing, compiled and archived data packages, and generated and revised GMP documents.
Quality Control Sample and Document Coordinator
Tunnell Consulting, Inc. at Spark Therapeutics
Jan 2017 - Jan 2018 (1 year)
Managed samples and associated documents for QC Laboratories, including shipping to contract organizations. Coordinated in-house testing, compiled and archived data packages, and generated and revised GMP documents.
Senior Consultant, Material Qualification Analysts
Tunnell Consulting, Inc. at Spark Therapeutics
Jan 2017 - Jan 2017 (0 months)
Coordinated material samples for qualification testing at contract laboratories and communicated with them. Logged document results from qualification testing, printed certificates of analysis for review, and assisted with procedure and process updates.
Floral Designer & Assistant Wedding Consultant
Marcus Hook Florist & Gifts
Jan 2005 - Jan 2017 (12 years)
Designed artistic floral arrangements and provided extensive one-on-one customer service. Managed wholesale ordering from international suppliers, product delivery, and venue set-up.
Education
Degrees, certifications, and relevant coursework
West Chester University
Bachelor of Science, Biochemistry
Activities and societies: Animal Enthusiast, working out, Marathons, Hiking
Completed a Bachelor of Science degree with a concentration and minor in Biochemistry. The curriculum provided a strong foundation in scientific principles and laboratory techniques.
Penn State University
Research Assistant, Chemistry Research
Researched the effects of E-cigarettes on the human body as a team leader of four. This research resulted in a published scientific article.
Penn State University
Small Group Study, DNA Modification
Explored DNA modifications in E.Coli and Salmonella, utilizing techniques such as DNA fragmentation and gel electrophoresis. Prepared a written report summarizing data and conclusions.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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