Karime Kofa
Burnsville,Minnesota
Summary
Detail-oriented Certified Root Cause Analyst with 5+ years of experience driving process improvement and quality management in regulated environments. Skilled in partnering with cross-functional and global teams to streamline business processes, improve operational efficiency, and support change management initiatives. Proven expertise in applying Lean and DMAIC methodologies, leading document control and CAPA/NCR initiatives, and implementing electronic Quality Management Systems (eQMS) to enhance compliance and performance. Adept at data analysis, facilitating workshops, and fostering continuous improvement cultures to deliver measurable business outcomes. Strong communicator with demonstrated ability to engage diverse teams and support enterprise-wide improvement programs.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Document Research Engineer – Legal Department
Xcel Energy
07.2024 - Current
- Led digitization of legal documentation, converting physical records into searchable OCR-enabled digital archives.
- Developed standardized tagging systems and naming conventions to enhance traceability and workflow consistency.
- Facilitated training sessions for legal teams on SharePoint navigation, improving document retrieval and access.
- Partnered with HR, compliance, and legal teams to ensure confidentiality, security, and accuracy of sensitive employee relations data.
- Identified gaps in documentation workflows and implemented process improvements that enhanced audit readiness.
Quality Systems Specialist II
Halozyme Therapeutics
10.2023 - 03.2024
- Reviewed and processed Change Requests (CRs) to ensure completeness and compliance with QMS procedures and regulations.
- Coordinated with internal teams to facilitate timely documentation changes and secure sharing with stakeholders.
- Led a team to implement CAPA action plans and improve document control processes in eQMS systems.
- Communicated change releases and managed associated training assignments across the organization.
Quality Systems Specialist III
Smith’s Medical
12.2021 - 02.2024
- Supported global QMS harmonization and integration initiatives across departments, ensuring compliance with FDA regulations and ISO standards.
- Collaborated with cross-functional teams to assess process impacts, maintain change control records, and implement approved changes.
- Worked closely with global teams to initiate and support Change Order (CO) creation processes, ensuring timely and accurate documentation.
- Delivered training and guidance to global and internal teams on change control procedures and best practices.
- Oversaw periodic document reviews, coordinating closely with document owners and stakeholders from both local and global teams.
- Facilitated continuous improvement efforts and participated in audits and targeted training sessions.
- Participated in stakeholder workshops and process mapping exercises to identify process inefficiencies and streamline workflows.
QA Specialist II / Sr. QA Inspector
Baxter Healthcare Corporation
05.2020 - 12.2021
- Supported CAPA investigations and root cause analysis, identifying solutions that improved product quality and reduced nonconformance.
- Managed site documentation systems, including archiving, retrieval, and destruction procedures.
- Participated in Operational Excellence and quality improvement initiatives, supporting process and system enhancements.
- Tracked investigation trends and supported data compilation for Quality Management Reviews.
Sr. QA Inspector /Senior Document Controller
Baxter Healthcare Corporation
11.2019 - 05.2020
- Led the Quality Finished Goods Inspection team and served as master trainer for inspection protocols and GMP compliance.
- Acted as NCR Investigator, Supported CAPA, and Change Control Task.
- Conducted manufacturing audits and improved compliance through procedural enhancements and training.
Education
Bachelor of Science - Technology – Quality Systems
Bowling Green State University
Bowling Green, OH05-2026
High School Diploma -
Park Center IB World School
Brooklyn Park, MN05.2018
Skills
- Business Process Improvement (Lean, DMAIC)
- Change Management & Stakeholder Engagement
- Data Analysis & Performance Tracking
- Process Mapping & Workflow Automation (Power Apps)
- Cross-Functional & Global Collaboration
- Quality Management Systems (QMS)
- Root Cause Analysis & CAPA/NCR Management
- Documentation & Knowledge Management (SharePoint, eQMS)
- Risk Management & Control Management
- Training & Development
Certification
Certified Root Cause Analyst
Timeline
Document Research Engineer – Legal Department
Xcel Energy
07.2024 - Current
Quality Systems Specialist II
Halozyme Therapeutics
10.2023 - 03.2024
Quality Systems Specialist III
Smith’s Medical
12.2021 - 02.2024
QA Specialist II / Sr. QA Inspector
Baxter Healthcare Corporation
05.2020 - 12.2021
Sr. QA Inspector /Senior Document Controller
Baxter Healthcare Corporation
11.2019 - 05.2020
Bachelor of Science - Technology – Quality Systems
Bowling Green State University
High School Diploma -
Park Center IB World School
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