Fred Diaz Jr
Sioux City,Iowa
Summary
Dedicated and highly ethical Quality Assurance (QA) professional with extensive experience in diverse pharmaceutical environments. Proven expertise in coordinating Immunoglobulin (IVIG) home infusion services and Specialized Pharmacy Services, effectively addressing the needs of Hemophilia, Neurological Disorders, and Immune-Deficiency communities. Strong background in conducting internal corporate audits, Interim Monitoring Visits (IMV), and for-cause audits across oncology, vaccine, and infectious disease research studies, ensuring a thorough understanding of regulatory compliance. Skilled in managing operations at a plasma donor center while maintaining adherence to GMP and GLP specifications and conducting both international and domestic GCP compliance audits.
Overview
22
22
years of professional experience
Work History
Quality Assurance Specialist III
Technical Resources International, Inc. (CRO+)
01.2022 - Current
- Conduct GCP remote and onsite audits of clinical research sites, internal corporate, and vendors/suppliers as assigned
- Travel as needed for onsite preparation of Food and Drug Administration (FDA) or Sponsor site audits in international and domestic settings
- Support the maintenance and upkeep of the Quality Management System (QMS)
- Assist in the Quality Assurance (QA) training program, document control, customer compliance program and CAPA program
- Support internal audit program and performance metrics system for continual improvement
- Assist in the review cycle of QA controlled documents to assure practices reflect written procedures
- Plan and conduct regular/random internal QA audits to ensure that all studies managed by Technical Resources International, Inc (TRI) are of the highest standard. Include in-process study inspections, data audits as well as table and report audits
- Preparation of site audit plans in both domestic and international settings
Quality Assurance Specialist
Meridian Clinical Research
09.2020 - 01.2022
- Conducted onsite internal audits at assigned regional research sites
- Traveled as needed for onsite audit preparation of FDA, Sponsor, or CRO audits
- Reviewed all clinical research associate (CRA)/monitor follow-up reports/letters for each site visit from the sponsor or clinical/contract research organization (CRO). Ensure that action items are completed, and a resolved response has been sent to the CRA in a timely manner.
- Assisted sites with compliance issues identified in the reports; reviewed corrective and preventative action (CAPA) plans and Notes to File as necessary
- Supported trial conduct and assist with protocol deviation tracking
- Supported source documentation creation and maintenance
- Attended and completed courses in state and Federal Food and Drug Administration (FDA) regulatory compliance, protection of Human Research Subjects (HSP), and Good Clinical Practice (GCP)
- Lead training for Meridian site staff on Good Clinical Practices (GCP), Good Documentation Practices (GDP), federal regulations, SOPs, guidelines, and other relevant documents for investigators and research staff
Assistant Manager - Operations
Octapharma Plasma, Inc.
12.2018 - 08.2020
- Ensured daily completion of donor center logs, shipping records, and review batch testing results
- Ensured that professional customer service, courtesy, and respect were practiced by staff to maximize donor retention
- Oversaw the performance of all equipment maintenance and ensure all equipment is well maintained and calibrated in compliance with Quality Assurance Program procedures
- Trained, developed, and managed center staff in accordance with Human Resource and company policies and regulations
- Provided on-site Human Resources Department representation and service functions
- Maintained donor center operations in a fiscally responsible manner in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Quality Assurance Programs (QA)
- Ensured operations were following State, Federal (FDA), and European Union regulations, OSHA requirements, and CLIA requirements
Clinical Research Assistant
Vitamed Research, LLC
02.2018 - 09.2018
- Supported Principal Investigator and Sub-Investigators in clinical research duties as delegated
- Submitted report forms and correspondence with Institutional Review Boards (IRB)
- Maintained and updated Study Regulatory Binders documents, (TMF) site training logs, and correspondence
- Collected and entered data from source documents and case report forms into studies’ electronic record database (EDC)
- Collected and documented completion of informed consent and California Bill of Rights forms
- Conducted recruiting and screening interviews of potential subjects for inclusion in clinical study
- Attended and completed courses in state and federal regulatory compliance, protection of human research subjects (HSP), and Good Clinical Practice (GCP)
Clinical Services Coordinator
NuFACTOR Specialty Pharmacy, Inc.
03.2004 - 12.2017
- Coordinated in-home nursing services including transmission of appropriate referral information, memorandum of understanding, and delivery date of biologicals
- Managed average caseload of 75 active clients
- Negotiated contract rates for client specific memorandums of understanding (MOU) within given profitability margin
- Tracked new referrals and participated in clearance and reimbursement discussions in morning interdepartmental rounds
- Completed initial Nursing Admit Note Assessment on new referrals, communicated to Admission Pharmacists pertinent information
- Reconciled invoices and skilled nursing visits notes reports
- Identified and resolved nursing service complaints from clients, reassigned clients as warranted
- Reported any issues or adverse reactions to appropriate clinical staff. Coordinated client care with Hemophilia Treatment Centers (HTC) across the United States
- Assisted in preparation of accreditation and reaccreditation by Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Utilization Review Accreditation Commission (URAC)
- Attended regional and national meetings of the National Hemophilia Foundation (NHF) and Immune Deficiency Foundation (IDF)
- Completed courses in state and federal regulatory compliance, protection of client privacy (HIPPA), and industry ethics
Education
Bachelor of Science - Human Services Management
University of Phoenix
San Diego, CA03-2012
Skills
- EDC, eTMF, ICH, GCP
- Quality control management
- Problem-solving skills
- Effective problem resolution
Affiliations
Society of Clinical Research Associates, Inc.
Languages
Spanish
Limited Working
Timeline
Quality Assurance Specialist III
Technical Resources International, Inc. (CRO+)
01.2022 - Current
Quality Assurance Specialist
Meridian Clinical Research
09.2020 - 01.2022
Assistant Manager - Operations
Octapharma Plasma, Inc.
12.2018 - 08.2020
Clinical Research Assistant
Vitamed Research, LLC
02.2018 - 09.2018
Clinical Services Coordinator
NuFACTOR Specialty Pharmacy, Inc.
03.2004 - 12.2017
Bachelor of Science - Human Services Management
University of Phoenix
MILITARY SERVICE
- Hospital Corpsman Pharmacy Technician, United States Navy
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