Quality Assurance Management
Resume:
Hakeem Broomfield
P.O. Box ****
Eugene, OR *****
Email: *********@*****.***
Professional Summary
Versatile Quality Assurance professional with over 10 years of experience in the Quality Engineering sector, particularly in life sciences and environmental sciences. Proven expertise in compliance with ISO standards (ISO 13485:2016, ISO 9001:2015) and a strong foundation in developing quality management systems and protocols. I am skilled in collaborative project execution, data analysis, training, and mentorship, with a focus on fostering a culture of quality within diverse teams.
Education
Alabama A&M University
MS in Plant and Soil Science, 2017
Huntsville, AL
Fort Valley State University
BS in Plant and Soil Science, 2012
Fort Valley, GA
Professional Experience
Quality Assurance Specialist, SIGA Technologies, Inc, Eugene, OR September 2023-Present
Spearheaded the successful implementation and continuous optimization of the Electronic Quality Management System (eQMS), ensuring full compliance with regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 11), while overseeing the transition from paper-based quality systems to a fully integrated electronic document control system
• Collaborated with IT during eQMS deployment; assisted with system configuration, automated workflows, and validation testing — laying foundation for QA automation skills
Managed the creation, approval, and oversight of electronic documents, workflows, and change control processes within the eQMS, ensuring adherence to compliance requirements and maintaining comprehensive traceability
Delivered regular training sessions for cross-functional teams on eQMS tools, processes, and best practices, fostering a culture of quality and promoting effective system usage across the organization
Provided training and mentorship to teams, enhancing proficiency and promoting the efficient use of eQMS functionalities
Collaborated closely with IT, quality assurance, and regulatory teams to ensure seamless integration, optimal performance, and ongoing functionality of the eQMS, driving operational excellence
Led the implementation of risk management strategies, supporting root cause analysis efforts for quality issues, and ensuring timely corrective actions
Contributed to the development and management of CAPA, change control, and risk management processes within the eQMS framework, ensuring effective mitigation of quality-related risks
Quality Assurance Engineer ThermoFisher Scientific Eugene, OR December 2021-September 2023
Facilitated and managed quality review and approval of all investigations, deviations, change controls, validation protocols and reports, SOPs, and in-process controls from key production teams
Drove complaints from internal and/or external customers to resolution in a timely manner
Provided quality oversight for suppliers internal to ThermoFisher Scientific, resolving quality issues in a timely manner and communicating status updates and outcomes to stakeholders and business partners
Conducted trend analysis of various types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects.
Developed a dashboard to visualize environmental monitoring data trends using Excel pivot tables and charts, enabling faster identification of cleanroom issues and reducing deviations by 15%
Recommended product revisions, process changes, and/or testing procedures to ensure that QMS standards are being attained
Created Validation Plans and other quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and or product quality
Reviewed Master Batch Records, specifications, and other pre-production documents for commercial products in compliance with ISO 9001 and 13485 and international health agency requirements
Released raw materials, in-process materials, components, and finished products
Participate as internal auditor for 9001 and 13485 and in external audits
Manage departmental projects and improvement initiatives through the site’s PPI
Wrote, reviewed, analyzed and revised written relevant Standard Operating Procedures (SOPs) and submitted procedural changes as needed to meet Site, Regulatory Requirements
QC/QA Laboratory & Regulatory Analyst New Earth Company Klamath Falls, OR January 2019- December 2021
Reviewed Master Batch Records, specifications, and other pre-production documents for commercial products in compliance with FDA and international health agency requirements
Assisted with 3rd party and regulatory audits: NSF, FDA, ODA, Kosher, Halal, Organic, etc
Carried out routine tasks accurately and follow strict methodologies and SOP’s
Facilitated and manages the CAPA program
Released raw materials, in-process materials, components, and finished products
Oversaw samples sent to contract labs and receipt of test results
Provided QA and QC functions to evaluate product quality and to meet or exceed requirements for testing
Developed and maintains an environmental monitoring program
Performed environmental monitoring activities in the cleanrooms such as air sampling and surface testing water and utilities for microbes and particulates and ensuring compliance with federal standards
Read EM plates/strips and document results on relevant forms
Monitored temperatures of Manufacturing and Microbiological QC temperature storage units
Tracked and Trended EM data including Microbial identification results in support for product release
Responsible for EM&C out-of- alert results documentation, including notification and re-testing of alert and action
Followed-up deviations, CAPA plans and change controls related to environmental monitoring
Interacted with vendors, personnel and customers to provide data and analytical support Protects confidential information
Managed data and information on diverse digital platforms
Produced reliable and precise data to support scientific investigation
Ensured that the calibration and verification of analytical instrument, the use of certified analytical reference standards of the equipment are established, prior use of equipment
Performed daily/monthly internal verifications of laboratory equipment
Performed analytical test procedures and operate analytical instruments (HPLC, HPTLC, and FTIR)
Handled instrumental (HPTLC, HPLC) and wet analysis of raw materials; investigation and deviation associated with raw materials
Conducted harvest QC sampling and testing (Speciation and Elisa Test)
Participated in monthly walkthroughs to ensure GMP/3rd party certification compliance
Maintained reminder calendars for expiration dates, calibration dates, vendor requalification dates, laboratory requalification dates, and other activities as needed
Program Coordinator Klamath County Public Health Klamath Falls, OR 2018-2019
Developed and coordinated community health profiles, or assessment of the most significant community health trends resulting in preventable disease and premature deaths
Explored and developed grant opportunities to fund various health promotion activities that meet the needs of the community
Prepared culturally appropriate health education/information materials in a variety of media
Prepared oral and written communication for officer review and approval
Participated in outreach activities to enhance community awareness of health issues, and engages the community in developing and implementing individual and collective actions
Knowledgeable of community needs, statistics, and resources, that are needed to relay accurate information and make informed referrals
Developed grant/funding opportunities for local health research and promotion
Coordinated health awareness events; Offer informative health information to the community
Collected and analyzes data on significant health trends and concerns; Develop statistical health profiles
Developed and supports community engaged research activities with OHSU and partners in Klamath and Lake Counties working to address needs identified in the Community Health Improvement Plan (CHIP) and other health improvement initiatives in the region
Established working relationships with federal, state, tribal and local agency partners to maintain natural resources management activities
Volunteer Work
Study Abroad Catie University Cartago, Costa Rica 7/2015-8/2015
Identified the aims of sustainable tourism that are linked to natural resource management, community-based tourism, and certification and marketing functions
Attained in-depth understanding of the challenges faced by the all-inclusive resorts wanting to work with the local communities
evaluated effects of alternative forest management practices
Acquired knowledge about the Certification and marketing in Sustainable Tourism (CST) program in Costa Rica Received training on Costa Rica s rural community-based tourism program – ACTUAR
Gained insight into the various obstacles faced by the industry when implementing best practices in sustainability and good practices in the use of resources in the hospitality industry in Costa Rica
Skills
Quality Management Systems: Qualio, Trackwise, JDE EnterpriseOne, Egnyte, Oracle Agile PLM
Data Analysis: Excel (including pivot tables and charts)
Regulatory Compliance: ISO 13485, ISO 9001, cGMP, cGLP
Software Proficiency: OneDrive
Lean Manufacturing & Continuous Improvement
Process Management
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