K GKG
Open to opportunities

K G

@kg0

Quality Assurance Specialist with expertise in compliance and regulatory affairs.

United States

What I'm looking for

I seek a role that fosters growth, values compliance, and encourages collaboration.

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

PI
Current

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.

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.

CB

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.

CB

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.

BC

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.

BI

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.

ST

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.

TT

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.

TT

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.

MG

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 logoWU

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 logoPU

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 logoPU

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

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K G - Sr. IT Systems Lead - ProKidney Inc | Himalayas