Quality Assurance Director - Environmental Resume Search
Quality Assurance Director - Environmental Resume Search
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Quality Assurance Director Resume


Desired Industry: Environmental SpiderID: 75270
Desired Job Location: Sandy, Utah Date Posted: 4/27/2015
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 65000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 25-50%
Highest Degree Attained: Other Willing to Relocate: No


Objective:
Hardworking, resourceful, and highly
analytical professional with more than
17 years of solid experience in the eye
banking field, encompassing surgical
recovery of ocular tissue for transplant
and research. Armed with in-depth
knowledge of sterilization processes,
ANSI/AMII standards, along with all
applicable regulations, standards, and
protocols. Known for high degree of
self-direction and initiative to
prioritize projects, coupled with
commitment to excellence, quality, and
safety of the organization. Powered with
strong ability to maintain positive
relations with professionals in the
industry, while streamlining processes
to educate and raise awareness.


Experience:
Professional Experience

Utah Lions Eye Bank, Salt Lake City, UT:
2003 ~ Present

Quality Assurance Director 2008 ~
Present

Capitalize on industry expertise in
developing and maintaining standard
operating procedures, as well as in
producing corrective and preventative
actions (CAPA), along with

change control and document staff review
forms
Ensure that training tools are properly
incorporated as well as document all
training sessions for appropriate
personnel
Guarantee that certifications, driving
safety course, annual skills
assessments, annual HIPAA, and
bloodborne pathogens are complied with
by conducting regular audits on

personnel training file and monitoring
technical and administrative staff
requirements
Manage event and complaints, including
evaluation, investigation, and risk
assessment of all non-compliant
manufacturing-related issues, such as
adverse events, tissue recalls,

and withdrawals
Accomplish monthly environmental
monitoring within the laboratory,
encompassing alarm testing, laboratory
cleaning, data logger downloads, and
supply and reagent verifications,

along with chart/recorded audits and
monthly tissue disposal logs
Make sure that supplies and reagents are
complete and have certificate of
analysis and safety data sheets prior to
placing into circulation
Work closely with the medical director
through coordination and facilitation of
monthly and quarterly meetings, as well
as preparation of quarterly summation
and trend reports

associated with quality activities
Administer the installation and
qualifications of all laboratory
equipment using the Installation
Qualification (IQ), Operational
Qualification (OQ), Performance
Qualification

(PQ), and Design Qualification (DQ)
methods
Render assistance with the assessment of
ocular tissue for transplant to define
donor eligibility and release of ocular
tissue for transplantation, research,
training, and

education purposes
Take charge of distributing three- to
six-month follow-up mailings for corneal
and scleral tissue transplantation
Perform scheduled internal and external
quality audits

Key Highlights:

Applied technical skills in creating and
executing software verification system
pivotal for the success of annual
verification and calibration of
manufacturing equipment
Led efforts in achieving four three-year
accreditations from the Eye Bank
Association of America (EBAA), as well
as three inspections from the Food and
Drug Administration (FDA)

with minimal to no findings
Contributed in the creation of an EK
program, along with an anterior and
posterior segment surgery option for
transplanting surgeons
Adopted innovative ideas in
conceptualizing Kiosk related to
donation and ophthalmology
(appointments), along with Q & A in the
field
Played a key role in ensuring compliance
of more than 1000 distributed HCT/Ps per
year with the established regulations by
performing investigations on adverse
reactions,

recalls, and product deviations

Technical Director 2003 ~ 2008

Provided continuous leadership and
guidance to technical staff of 10
through facilitation of training in
various fields, including the
procurement of donor tissue
Kept up-to-date with EBAA, FDA, UAGA,
and OSHA standards and regulations to
ensure impeccable laboratory operations
Harmonized the release of transplant and
research tissue, as well as the final
evaluations of corneal tissue and final
serology and laboratory results in
compliance with all

regulations
Performed human resource functions, in
charge of interviewing, hiring, and
training of technical staff on all
technical areas
Supported the maintenance and
enforcement of Utah Lions Eye Bank
standard operating procedures, along
with Moran Eye Center and University
policies
Effectively functioned as an interim
executive director within six months
Established a research program and
headed research distribution outlets for
all eye banks in the nation to help cure
the causes of blindness and glaucoma
Key Highlights:
Gained proficiency in medial chart
review and terminology to support the
recognition of donor and tissue
suitability
Made major contributions in developing
and executing quality assurance (QA)
standard operating procedures
Assumed full responsibility in handling
the final release of research and
surgical tissue that were time sensitive
and must be released the soonest
possible time to maintain its

quality
Developed the Volunteer Courier Program
through the Lions Club Association which
continuously grew and implemented by the
organization



Earlier Experience

San Diego Eye Bank, San Diego, CA

Quality Control Coordinator and Recovery
Technician 1997 ~ 2003

Sycuan Gaming Commission, El Cajon, CA

Surveillance Investigator 1995 ~
1997
911 Dispatcher 1993–1995


Education:
Coursework in Fire Safety | Miramar Fire
Academy, San Diego, CA
Coursework in General Education |
Grossmont College, San Diego, CA


Affiliations:
Professional Affiliations

Eye Bank Association of America (EBAA)
Eye Banks Across the Nation and
throughout the World FDA
Hospitals, Mortuaries, and the Medical
Examiner’s Office, State of Utah,
Eastern Wyoming, and Northeastern Nevada
Intermountain Donor Services (Tissue and
Organ Recovery Agency)
JACHO/DNV
John A. Moran Eye Center (OR, Clinics,
Executive Offices, Research
Laboratories)
Occupational Safety and Health
Administration (OSHA)
Utah State Health Department
Serology Testing Facilities (VRL, LABS,
Inc.)
University of Utah (Human Resources,
Risk Management, Motor pool, Learning
Management Systems)
University of Utah Hospital (Quality
Assurance/Accreditation, Sterile
Processing, BioMed, Facility Engineers,
Electricians)


Skills:
Quality Control and Assurance
Environmental Monitoring
Document Control
Quality Improvement
Internal and External Audits
Software Verifications
Process Validations
Policies and Procedures Development
Regulatory Compliance


Additional Information:
Professional Training

Health Insurance Portability and
Accountability Act/ Learning Management
System (HIPAA/LMS)
Safety CAT and Bloodborne Pathogens
Annual Assessment and Driving Safety
Course Requirements
Endothelial Keratoplasty (EK) Processing
Courses
Medical Terminology Courses
Microsoft Word I, II, and III
Slit Lamp Biomicroscopy and Specular
Microscopy
Excel I, II, and III Classes
Release of Corneal Tissue for
Transplantation
Toastmasters
Advanced Designator Requestor Training
Continuing Education Workshops within
the Eye Bank Association of America
(EBAA)



Credentials

Certified Eye Bank Technician (CEBT)
Certified in Medical Terminology
Federal Emergency Management Agency
(FEMA) Certified



Awards and Honors

Circle of Excellence: 2004 ~ 2012
I Made it Happen Awards: 2004 ~ 2012
Multiple Thank You Cards from the John
A. Moran Eye Centers Management Team



Professional Affiliations

Eye Bank Association of America (EBAA)
Eye Banks Across the Nation and
throughout the World FDA
Hospitals, Mortuaries, and the Medical
Examiner’s Office, State of Utah,
Eastern Wyoming, and Northeastern Nevada
Intermountain Donor Services (Tissue and
Organ Recovery Agency)
JACHO/DNV
John A. Moran Eye Center (OR, Clinics,
Executive Offices, Research
Laboratories)
Occupational Safety and Health
Administration (OSHA)
Utah State Health Department
Serology Testing Facilities (VRL, LABS,
Inc.)
University of Utah (Human Resources,
Risk Management, Motor pool, Learning
Management Systems)
University of Utah Hospital (Quality
Assurance/Accreditation, Sterile
Processing, BioMed, Facility Engineers,
Electricians)



Activities

Emergency Safety Committee Member and
Floor Marshall: 2008 ~ Present
Annual 5Ks (Dash for Donation)
Participant
Annual Celebration of Life Monument
Ceremonies Participant



Technical Skills

Software
Microsoft Office (Word, PowerPoint, and
Excel I, II, III)
Internal Database
Equipment
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Slit Lamp Biomicroscopy
Specular Microscopy
Optical coherence tomography (OCT)
Laminar Flow Hood/Biological Safety
Cabinet (LFH/BSC)
Refrigerators and Freezer
Operating Scope
ISO Class 7 Clean Room
Heating, Ventilating, and Air
Conditioning (HVAC) Installation
Moria Equipment
Pachyometer
Centrifuge
Sonicator’s
Vaisala Monitoring Equipment
Alarm Notification Systems
Vaisala, Dickson Data Loggers,
Sensaphone/Forma Alarm System


Reference:
Available upon request.


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