Summary
Overview
Work History
Education
Skills
Websites
Certification
Affiliations
Timeline
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CHRISTIE CARDENAS

San Antonio,TX

Summary

NURSING PROFESSIONAL / OPERATIONS ASSISTANT DIRECTOR A servant leader with over 28 years of combined management and clinical experience.

Overview

26
26
years of professional experience
1
1
Certification

Work History

Global Compliance & Regulatory Specialist

Nvision Biomedical Technologies Inc./Sequence LifeScience
12.2023 - Current
  • Develop and maintain a comprehensive understanding of applicable regulations and standards, including FDA 1271 & 820 CFR, AATB, and ISO regulations and applicable worldwide standards and requirements
  • Assists with development, implementation & reviews of protocols, contracts, submissions, medical device design plans, etc
  • To ensure compliance with internal standard operating procedures, federal and local regulations
  • Assist all Nvision sales representatives in town and out of town with the credentialing process for all respective area hospitals
  • Assist with managing Device Master Records (DMRs) and facilitation with contract suppliers
  • Assist with evaluating product failures and generating the investigation report with the assistance of engineering and Tissue Operations
  • Assist in maintaining FDA GUDID
  • Design and develop validation plans, protocols, data sheets for equipment qualifications and process validations with Biomedical Engineers
  • May serve as QA point of contact in multi departmental projects as assigned by Quality Assurance Regulatory and Compliance Vice President
  • Responsible for tracking and submitting annual reporting of payments and transfers of value as it relates to the Sunshine Act for Nvision Biomedical Technologies, Inc
  • Maintain Nvision & affiliated companies safety policies and OSHA standards
  • Assist with managing and tracking regulatory submissions, including FDA 510K, state licensing, and annual reports
  • Provide guidance and support when needed to cross-functional teams on regulatory and compliance matters
  • Maintains and completes regulatory submission documents and ensures they are submitted prior to deadlines
  • Develop and implement LEAN processes to ensure compliance with regulations and standards
  • Manage/conduct internal audits to assess compliance with regulations and standards, coordinate and manage audit schedules, correspondence and formulating closing audit findings reports
  • Manage collaboration with external audits and schedules by regulatory authorities or customers/suppliers
  • Communicates with vendor representatives and suppliers for vendor qualification standards
  • Attend audits, meetings, seminars, and other workshops as required
  • Travel may be required
  • Maintain confidentiality of all medical records and information, which pertains to birth tissue donor specimens, employees, the organization, and any client proprietary information provided
  • Provide compliance & regulatory resources by providing required collaboration and input for new projects, medical device development, manufacturing and distribution of medical devices, and birth tissue.

Donor Center Director (Registered Nurse)

Octapharma Plasma Inc.
10.2021 - 10.2023
  • Manages and oversees donor center medical staff of 50 or more and overall regulatory operations
  • Responsible for oversight of plasma production, Key performance indicators, quality compliance, finance, timecards, HR performance evaluations, and IT
  • Donor education interactions and customer service
  • Acts as a liaison with all corporate functions to ensure center compliance and performance
  • Maintains compliance with SOP, current Good Manufacturing Procedures (cGMP), and regulatory guidelines for the plasma industry
  • Responsible for ensuring the safety of donors and staff while on Octapharma premises
  • Responsible for ensuring all building maintenance is fixed in a timely manner and within center budget restrictions
  • Responsible for all marketing campaigns and printing for respective center
  • Responsible for management of Google and Bird’s Eye review by Octapharma donors
  • Responsible for oversight of scheduling all weekly plasma collection shipments.

Registered Nurse, Field Skilled Nurse

Bright Star Home Care Services
06.2021 - 10.2021
  • Direct patient care with patients in their home environment
  • Experience in wound vacs, PICC lines, IV antibiotic and TPN administration, venipuncture lab draws, basic wound care with RN recommended wound treatment
  • Oversight of patient safety while at home
  • Medication management, medication and diagnosis teaching for patients and family members
  • Completing multi-systems assessments, patient teachings, computerized patient charting and documentation on KanTime
  • Patient scheduling skills and excellent time management.

Lead RN Collection Coordinator

GenCure
08.2020 - 06.2021
  • Responsible for managing the donor’s eligibility criteria to the final disposition of the cord blood, placenta and umbilical cord tissue collection to include the supervision of Collection Program Coordinators and/or Nurse Coordinators
  • Educate hospital nurses, physicians, surgical techs and hospitals administrators at potential collection sites to enter into a contract agreement and collaborate with GenCure management to schedule and develop a plan for the additions or potential closing of collection sites if warranted
  • Assist the Collection Program Manager with recommendations and implementation of major operations, organizational improvements and the balance of clinical initiative and business needs for GenCure’s Cord Blood Center pertaining to the collection of cord blood, placental and umbilical cord tissue products
  • Create and provide education activities/materials for obstetricians, obstetrical office staff, expectant donor mothers, and hospital nursing staff on cord blood, placental and umbilical cord tissue collection procedures for initial collections
  • Ensure staff changes that may occur at collection sites are immediately informed of procedural revisions as necessary
  • Develop cord blood, placental and umbilical cord tissue collection stand operating procedures according to the, IRB, AATB, AABB, FACT, ISO, FDA and GMP standards
  • Meet with Collection Program Coordinator, Nurse Coordinators individually and/or collectively at monthly staff meetings to encourage and discuss performance goals and identify any needs to be addressed
  • Offer daily support to all collection sites regarding collection process, regulatory requirements, donor eligibility, and education for obstetrical providers, hospital staff and donors
  • Provide monthly feedback reports to the Manager of Research & Clinical Services on performance, collection goals, and training issues
  • Assist the Manager of the Research & Clinical services with the creation of appropriate performance improvement plans.

RN Supervisor, Collection Coordinator, Cord Blood and Birth Tissue Program

GenCure
11.2018 - 08.2020
  • Responsible for managing the front and end of cord blood, placenta and umbilical cord tissue collection to include the supervision of Collection Program Coordinators and/or Nurse Coordinators
  • Interface with nurses, physicians, and hospitals administrators at potential collection sites to enter into a contract agreement and collaborate with GenCure management to schedule and develop a plan for the addition or closing of collection sites
  • Assist the Collection Program Manager with planning and implementation of major operations, organizational improvements and the balance of clinical initiative and business needs for GenCure’s Cord Blood Center pertaining to the collection of cord blood, placental and umbilical cord tissue products
  • Coordinator and provide education activities/materials for obstetricians, obstetrical office staff, expectant mothers, and hospital nursing staff on cord blood, placental and umbilical cord tissue collection procedures for initial collections, when staff changes occur at collection sites, and for procedural revisions as necessary
  • Develop cord blood, placental and umbilical cord tissue collection procedures according to the AATB, AABB, FACT, ISO, FDA and GMP standards
  • Meet with Collection Program Coordinator, Nurse Coordinators individually and/or collectively on a regular basis to discuss performance goals and identify any needs to be addressed
  • Offer daily support to all collection sites regarding collection process, regulatory requirements, donor eligibility, and education for obstetrical providers, hospital staff and donors
  • Provide monthly feedback reports to the Manager of Research & Clinical Services on performance, collection goals, and training issues
  • Assist the Manager of the Research & Clinical services with the creation of appropriate performance improvement plans.

Registered Nurse I (Transplant Care Unit)

Methodist Specialty and Transplant Hospital
08.2018 - 11.2018
  • Vital member of the nursing team caring for recent kidney, liver or pancreas organ recipients and or donors by applying nursing judgement through a thorough, systematic approach of applying the nursing process to include: Assessment, Planning, Implementation, and Evaluation
  • Collaborate with patient care team members on patient care plans, communicates timely and effectively with physicians and other members of the patient care team through verbal, written and electronic communication to coordinate and facilitate meeting patient needs
  • Demonstrates critical thinking skills, scientific judgment and organizing skills
  • Makes accurate and complete and timely entries into the patients’ medical records addressing all steps of the nursing process
  • Communicates with members of the healthcare team, patient and patients’ family.

Service Coordinator/Nurse

Superior Health Plan Temp Employee
04.2017 - 10.2017
  • Vital member of the Centralized Authorization Team where I Assisted Adult Day Care facilities located throughout South Texas with final insurance authorizations
  • Called and assisted facility nurses and facility Directors with proper nursing assessment documentation for required insurance eligibility for annual patient attendance
  • Provided education to members to foster compliance with program and positively impact outcomes
  • Provided procedural improvement recommendations to assist with streamlining current authorization procedures in team meetings with the Service Coordinator, Supervisor and Director
  • Assisted with training of new temp
  • Employees for the Central Authorization Team when needed.

Assistant Director of Donor Services Operations

South Texas Blood and Tissue Center
01.1998 - 02.2017
  • Directed (3) Managers, (4) Supervisors, (3) LVN’s (Donor/ Patient Advocates) and staff of 120 employees (Phlebotomist)
  • Oversaw Mobile Operations to include oversite of seven Fixed Site’s and staff scheduling in conjunction with Donor Recruitment’s mobile collections schedule with focus on DASH rate/ donors processed per hour
  • Hired, trained, supervised, and evaluated staff; enforced organization and departmental policies, CFR procedures, and conducted annual competency evaluations
  • Responsible for regulatory audits including FDA, AABB, OSHA, ISO, EU and internal audits
  • Assisted in writing, implementing of and ensuring compliance of all departmental and relevant SOPs, CFR Policies and cGMP
  • Responsible for oversight of all staff schedules, payroll, PTO, overtime and HR issues
  • Tracked and trended staff key performance indicators (KPI) for increased productivity and efficiency
  • Ensured that all equipment was calibrated (QC), validated, tracked and maintained to meet current quality and operational requirements
  • Worked with multiple vendors (capital-based expenses) on maintenance, instrument operations and training for Apheresis-based Cell Counters RBC’s, Platelet and WBC and various apheresis collection technologies used for donor/patient blood component collections
  • Conducted monthly staff meetings to inform staff of goals, successes, opportunities for improvement and overall departmental communication.

Education

Bachelor’s Degree In Nursing - Nursing Administration

University of Texas At Arlington
Arlington, TX
05.2024

RN, ADN - Nursing

National American University School of Professional Nursing
San Antonio, TX
06.2018

Diploma (LVN) - Nursing

Baptist School of Nursing
San Antonio, TX
08.1995

Diploma -

East Central High School
San Antonio
05.1992

Skills

  • Microsoft Applications: Word, Excel, PowerPoint, Visio
  • Forecaster (Budget and line-item monitoring)
  • SAP (Ordering and financial analyses)
  • Lifetrak/Hemasphere (Scheduling software for staff and blood drives)
  • Safetrace/El-Dorado/LifeTrak (Blood Establishment Computer System (BECS)
  • Meditract (Contract software)
  • TruCare (Population Health and Care Management Platform)
  • Go to Meeting/Webex (Conferencing)
  • Meditech (Patient Hospital Charting)
  • Pyxis MedStation (Automated Dispensing System)
  • Health Stream (Online training program)
  • KanTime (computerized charting) Medicare and Medicaid
  • Nexlynk (Plasma Establishment Computer System)

Certification

Certified Tissue Bank Specialist Certification by the American Association of Tissue Banks (AATB)

Affiliations

  • American Association of Blood Blanks (AABB)
  • South Central Association of Blood Banks (SCABB)
  • Blood Centers of America (BCA)
  • American Society for Apheresis (ASFA)
  • American Association of Tissue Banks (AATB)

Timeline

Global Compliance & Regulatory Specialist

Nvision Biomedical Technologies Inc./Sequence LifeScience
12.2023 - Current

Donor Center Director (Registered Nurse)

Octapharma Plasma Inc.
10.2021 - 10.2023

Registered Nurse, Field Skilled Nurse

Bright Star Home Care Services
06.2021 - 10.2021

Lead RN Collection Coordinator

GenCure
08.2020 - 06.2021

RN Supervisor, Collection Coordinator, Cord Blood and Birth Tissue Program

GenCure
11.2018 - 08.2020

Registered Nurse I (Transplant Care Unit)

Methodist Specialty and Transplant Hospital
08.2018 - 11.2018

Service Coordinator/Nurse

Superior Health Plan Temp Employee
04.2017 - 10.2017

Assistant Director of Donor Services Operations

South Texas Blood and Tissue Center
01.1998 - 02.2017

Bachelor’s Degree In Nursing - Nursing Administration

University of Texas At Arlington

RN, ADN - Nursing

National American University School of Professional Nursing

Diploma (LVN) - Nursing

Baptist School of Nursing

Diploma -

East Central High School

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CHRISTIE CARDENAS