Quality Assurance Continuous Improvement

OBJECTIVE

Seeking a professional role within a humanitarian organization with opportunity to apply extensive experience in quality assurance, regulatory compliance, and team leadership to contribute to organizational growth and impact.

PERSONAL PROFILE

Results driven Quality Assurance Manager and Auditor with over four years of experience in biotechnology and pharmaceutical or life sciences environments. Proven expertise in leading GMP compliant quality systems, internal and external audit management and continuous improvement strategy and implementation. Skilled in regulatory compliance (CLIA, FDA, OSHA, AGES, EMA, PPTA), supplier quality management, CAPA and risk management. Adept in cross functional collaboration, team leadership and inspection readiness. Committed to maintaining high product quality standards and fostering a positive culture of compliance and accountability. Systems skills include: PowerBI, Lims, SAP, and EPIC. Proficiency in skilled applications include: Microsoft Office Applications, NexLynk, DMS and eQMS systems such as MasterControl and SmartSolve, Tutela, Schedule 360, eClinicalWorks, Kronos, UKG, ePocrates, Time Slips, Westlaw, Loansome Doc, and PubMed.

PROFESSIONAL EXPERIENCE

October 2024-March 2025 Quality Assurance Auditor II, Cel-Sci Corporation

Maintain expert knowledge of SOPs, cGMP, and regulatory requirements of 21 CFR Part 210 and 21 CFR Part 211 and regulatory agencies such as the MD Board of Pharmacy, OSHA, FDA and EMA

Plan, schedule and perform internal and external GMP audits (manufacturing, laboratories, packaging, suppliers, and vendors)

Prepare detailed audit reports and communicate results to leadership and stakeholders

Assist with development and continuous improvement of audit process, SOPs, policies, training and risk based audit strategy

Support and monitor data integrity, validation, deviation, CAPAs and effectiveness, non-conformance, out of specification, complaint, change control investigations and inspection readiness

Review and release of raw materials for research, testing and manufacturing

Perform QA on the floor activities: room clearance, observation of critical processes and technical review of batch record documentation in real time

Perform verification of Quality Manual Visual Inspection of pharmaceutical drugs for release

March 2022-October 2024 Quality Assurance Manager, Octapharma Plasma

Maintain expert knowledge of SOPs, cGMP, and regulatory requirements of 21 CFR Part 640.60 and governing agencies such as CLIA, FDA, OSHA, AGES, and PPTA

Maintain expert knowledge of donor center operations and provide direction for continuous risk mitigation and process improvement

Oversee investigation and documentation of deviations, non-conformances and incidences and ensure root cause analysis and effective implementation of CAPAs

Tracking and trending of donor center activities and quality metrics to support continuous improvement

Maintain audit readiness through process of self-inspection and compliance monitoring

Manage and host regulatory audits with Internal Audit, CLIA, FDA and AGES audits and manage response to such

Manage controlled documents including SOPs, policies and records

Assist with review, revision and implementation of updated SOPs, policies and training

Oversee record review and inventory management

Supervise, mentor and train Quality staff

Cross functional collaboration with operations management and staff, medical affairs personnel and regulatory departments to support donor center initiatives

August 2021-March 2022 Quality Assurance Technician, Octapharma Plasma

Monitor donor center activities to ensure compliance with SOPs, cGMP and regulatory agencies: CLIA, PPTA, FDA and AGES

Perform quality checks on donor records, maintenance and calibration records, documentation and sample and product storage and release and assist with inventory management of plasma product

Inspect and verify suitability of donors, plasmapheresis materials, plasma samples and plasma product

Review manufacturing records and actions associated with unsuitable test results, Health Department reporting and subsequent product destruction in accordance with regulatory standards for disposal of biohazardous waste

Assist with maintenance of quality systems in accordance with cGMP, 21 CFR Part 640.60 and SOP

Assist with regulatory audits with Internal Audit, CLIA, FDA and AGES audits

May 2021-July 2021 Human Resources Coordinator, MedFast Urgent Care

Assist with interview and hiring process, onboarding and conduct drug screenings of new hires

Conduct 30 day review with new hires and maintain communications with the Training Manager to ensure completion of new hire, annual and ongoing training completion

Manage scheduling of administrative and clinical staffing at 13 company locations (78+ employees)

Manage and approve shift changes and time off requests

Mitigate and/or escalate interpersonal staffing conflicts to the Human Resources Manager

July 2020-May 2021 Clinical MA/Clinical Supervisor, MedFast Urgent Care: Rockledge

Triage patients; obtain medical history, document chief medical complaint, take and record vital signs

Perform testing as ordered by physician on duty including EKG, administer medication

Perform venipuncture, injections, and standardized tests as required per Department of Transportation, Brevard County Public Schools and various contracted employer’s for standard physical requirements

Set up and maintain a sterile field and assist medical provider with minor procedures

Administrative duties including patient check in, insurance verification, payment processing, referral processing, maintain patient privacy in compliance with HIPAA standards

Proper care and disposal of biomedical waste and ensure compliance with regulatory requirements

Ensure completion and accuracy of chart documentation and accuracy of CPT and ICD9 codes prior to submission to billing department

Oversee and coordinate day to day operations of clinic including staff and patient safety, reporting, workflow, and supply and inventory maintenance, and equipment maintenance

October 2019-July 2020 Donor Floor Supervisor, Immunotek Bio Centers, LLC

Ensure operational compliance with state, Federal and International regulations (OSHA, CLIA, GMP, FDA, and AGES)

Train and mentor Donor Center Technicians and Phlebotomists

Partner with Quality Assurance and Donor Center Management to ensure favorable donor floor performance and implement continuous improvement strategies

Assess donor eligibility, perform phlebotomy, operate plasmapheresis machines, and monitor donor safety

Response, evaluation and documentation of autopheresis procedures and troubleshooting displays, respond and assist with emergency medical intervention as needed

Proper care and disposal of product and biomedical waste

May 2017-April 2019 Owner/Family Child Care Provider, GillYARD Family Play School

Child development and curriculum planning for all ages

Attendance tracking, meal planning, execution and documentation of daily meals and all activities

Budget planning, management of expenses and mileage for taxation

Parent communication and engagement

Develop and maintain SOPs for licensing and regulatory compliance via USCG

July 2010-Present Domestic Engineer, Gillyard Family Household

Manage and organize logistics including budget, scheduling (four individuals) and maintenance

Create and provide a positive environment by fostering emotional and social development by providing emotional safety, behavioral guidance and developmental enrichment

Provide full time care including plan and preparation of meals, coordinate education and extracurricular activities, and provide transportation

Lead crisis and conflict resolution

Implement continuous process improvement to improve efficiency and improve cost savings

February 2009-July 2010 Administrative Assistant/Paralegal, Nash and Associates, LLC

Request, review, collate and maintain client medical records; draft meeting minutes during client and medical expert meetings

Maintain esquire billing, filing and tracking systems, and calendars for up to four esquires specializing in medical malpractice and personal injury

Assist in coordination of experts, witnesses, deposition and discovery and coordinate logistics of such

Conduct medical research, prepare medical chronologies, and summarize medical records and bills

Conduct research on case law, statues and regulations and draft legal documents

CERTIFICATIONS

●Phlebotomy (Eastern Florida State College Competency)

●Lab Corps: Forensic Urine Drug Screen Collector

●Internal GMP Audit & Role of GMP Auditor

●Manual Visual Inspection of Injectable Pharmaceutical Drugs

●ISO Clean Room 5, 6, 7 and 8

EDUCATION

August 2025-Present University of Maryland Global Campus

Bachelor’s Degree in progress in Health Services Management.

January 2020-June 2021 Eastern Florida State College

Certificate of completion: Medical Assistant. Coursework included, but was not limited to Anatomy and Physiology, Medical Coding ICD 9 and ICD 10, Basic X-Ray Machine Operator, and Phlebotomy.

June 2009-May 2011 University of Phoenix: Axia College

Associate’s degree in Health Administration with a focus in medical records.

Aug. 2004-May 2008 Parkville High School

EXTRACURRICULAR ACTIVITIES

July 2012-May 2019 Coast Guard Spouses Association

Served as a member of both the Boston, MA and Cape May, NJ sectors of the Association, which is representative of Coast Guard spouses amongst active duty members serving within the United States Coast Guard. The purpose of the Association is to provide resources to enhance preparedness and increase resiliency of Coastguardsmen and their families, and boost morale. The Cape May sector provides equal focus of support and morale boost efforts amongst families and recruits as they move through the various stages of recruit boot camp.

July 2005 National Youth Leadership Forum on Medicine; Phoenix, AZ

The National Youth Leadership Forum on Medicine (NYLF/MED) is the nation's foremost program in pre-medical education for high school students. The NYLF/MED utilizes a hands-on, interactive curriculum that includes clinical and research visits.

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