QA/RA Specialist, EH&S Specialist
Resume:
Deanna O'Brien
Oak Ridge, Tennessee 37830, USA
Home Phone: 865-***-****
Cell Phone: 865-***-****
********@*********.***
SUMMARY
Professional with 20 years experience in Laboratory Management,
Technology, Applications. Worked with the State of Tennessee in
developing new test requirements for proficiency testing. Years of
experience writing test protocols, validations, SOPs, and personnel job
descriptions. History of managing clinical and research laboratory staff
and managing budgeting for equipment and expansions.
CERTIFICATIONS
• Medical Technologist - American Society for Clinical Pathology, Chicago,
Illinois, 1991 - Present. Local Representative on the ASCP Laboratory
Council for the Southeast Region.
• Clinical Laboratory Scientist - National Certification Agency for Laboratory
Sciences, Washington, DC, 1991 - Present
• Medical Laboratory Professional - State of Tennessee, Board of
Laboratory Medicine, Nashville, TN, 1991 - Present
• Medical Laboratory Supervisor - State of Tennessee, Board of Laboratory
Medicine, Nashville, TN, 1998 - Present
COURSES
Human Resource Management
Clinical Laboratory Management
EDUCATION
Lincoln Memorial University, Harrogate, TN
Medical Technology, Minor: Concentration in Analytical Chemistry,
1991
GPA: 3.70, Major GPA: 3.75. Graduated 1st in class with honors
HONORS & AWARDS
• ASCP National Laboratory Council Representative - American Society for
Clinical Pathology, Chicago, Illinois, 2012 - Present.
Invited to serve as representative for the Southeast Region. As a
representative I am asked to review and comment on the impact of
legislative changes, reimbursement changes by CMS and new personnel
requirements. I also speak to students about becoming a Medical
Technologist/Clinical Laboratory Scientist.
INTERESTS
• Travel, Cooking new dishes even when they don't turn out well.
LANGUAGES
• Spanish
EXPERIENCE
ProNova Solutions, Knoxville, TN
Radiation Safety Officer, Environmental Health and Safety Officer,
2013 - Present
Served as Liaison for FDA, State of TN Dept of Radiological Health, Health
Canada, EU and other regulatory bodies as necessary. Assist with
implementation of ISO 13485, QMS systems and Document Control
systems. Adapted recognized health, safety, and environmental standards
to meet the specific needs of remote international countries/locations.
Calibrated and maintained laboratory sample counting equipment and
survey instrumentation. Assisted in regulatory affairs, environmental
monitoring and design. Developed a procedure manuals for Environmental
Management and Radiation Safety. Responsible for all safety and radiation
training for staff.
LabConnect LLC, Johnson City, TN
Manager Quality Assurance, 2013 - 2013
Responsible for writing and maintaining the company's Global Quality
Program with affiliate laboratories from several countries. 21CFR part 11
oversight, clinical trials regulatory oversight, and supplier/vendor
qualification and management oversight.
DeRoyal Industries, Powell, TN
Senior Specialist, Regulatory Affairs and Biocompatibility testing,
2011 - 2013
Changed Corporate Design Control Program to make it streamlined
and easier to follow. Trained staff on the new program.
Wrote procedures and templates for process validation
Authored and submitted 510(K)s for new products
Reviewed results for biocompatibility testing (cytotoxicity,
pyrogenicity, microbial contamination, residue levels)
EDP Biotech Corp, Knoxville, TN
Director of QA and RA, 2010 - 2011
Part of a team that consisted of scientists and business professionals
tasked with developing a test for colon cancer. My function on the team
was as the director of QA and RA.
My duties included,
Validated newly built clean rooms
Designed and Implemented Microbiology testing lab
Authored Quality Manual and SOPs in the Operations Manual
Conducted supplier audits
Daxor Corporation, Oak Ridge, TN
Vice President of Quality Systems and Regulatory Affairs, 2003 -
2010
Directed all quality and regulatory activities for a medical device and
radiopharmaceutical company.
Wrote protocols and implemented laboratory instrumentation IQ, OQ,
and PQ validation system on HPLC instrument, spectrophotometer and
lab DiH2O systems among others.
Developed document control system and change controls.
Conducted multiple off-site supplier audits as well as yearly audit
questionnaires for less critical suppliers.
SKILLS
• Quality Assurance
• Regulatory Compliance
• Healthcare
• Analytical Test Methods
• FDA
• Cell Culture
• Process and Equipment Validation
VOLUNTEERING & CAUSES
Children's Hospital, Ronald McDonald House, Knoxville, TN
Volunteer, 2012 - Present
Meet with other volunteers to cook dinner for families staying at the Ronald
McDonald House because they have children who are long term patients at
Children's Hospital.
Health Screens, Knoxville, TN
Screening Tech, 2012 - Present
Work a local parents group through the PTO to do health screenings for
children who don't get access to regular healthcare.
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