Quality Assurance Customer Service
Resume:
Renaye Hecker
Clinical Lab Scientist/Trial Coordinator
Buffalo, NY 14224
eym5mx@r.postjobfree.com
Employment History:
Frontier Science-Data Management Center for International Clinical Trials
4033 Maple Road
Amherst, NY 14226
2/7/11-present
Clinical Trials Coordinator-Breast International Group/IBCSG international breast cancer clinical trials
• Liaison of communication between Coordinating Center in Switzerland, Data Management Center in Boston, MA and global centers
• Collects and tracks regulatory documents for new center activations, closures, protocol amendments and other for clinical trials
• Coordinates data management software and IBCSG website access for centers
• Coordinates clinical trial and IBCSG trainings for new centers
• Maintains Excel spreadsheets of center status tracking lists, center contact lists and other
• Report preparation and projects ongoing
Catholic Health System-St Joseph Hospital
2605 Harlem Road Cheektowaga, NY 14225
716- 891-2400
7/25/11-1/12
Clinical Lab Scientist (MT)-Generalist, per diem
Roswell Park Cancer Institute
Elm & Carlton Street
Buffalo, NY 14263
8/26/10-2/4/11
Clinical Lab Scientist, Flow Cytometry Lab (Dr Paul Wallace)
The Outer Banks Hospital
Nags Head, NC
11/10/08-7/23/2010
Clinical Lab Scientist, Generalist 3rd shift
Catholic Health System
Kenmore Mercy Hospital
2950 Elmwood Avenue
Kenmore, NY 14217
7/30/07-11/7/2008
Laboratory Supervisor/Mgr
• Urgent Response Laboratory to include 32 employees consisting of Core Lab, Blood Bank, Pathology, Processing, and Outpatient Phlebotomy Departments
• Responsible for payroll and scheduling
• Budget review and preparation, monitors operating costs
• Joint Commission and state regulatory standards oversight
• Purchasing
• Performance Evaluations and personnel related functions (hiring, firing, discipline, etc)
• Quality Systems Management (QA)
• Prepares reports, special projects for senior management
Erie County Public Health Lab
462 Grider Street Clinical Center AA
Buffalo, NY 14216
9/25/06-7/27/07
Supervisor of Specimen Processing & Quality Systems Manager (QA)
• Managing of the Specimen Processing and media making/Scientific Support area to include scheduling, managing detailed Excel spreadsheets of monthly testing submitter statistics, problem solving, training, and implementing changes for continued growth.
• Engaged in ordering of supplies and customer service to manage materials utilized in the Microbiology Lab and other.
• Coordinating a Quality Assurance program to include internal audits, focus audits, quality indicators, incident reports, data reduction/validation/reporting, procedures for implementing and documenting corrective actions, ethics training, data integrity investigations, preparation and coordination of inspections, and chairing monthly QA meetings.
• Working in partnership with the Lab Director in Quality Systems Management, marketing, and proposed technical writing projects.
3/6/06-9/25/06 (ECPHL)-Molecular Diagnostics
Lab Tech-Emerging Infections/Biodefense Lab (Molecular & Microbiology)
• Work with select agents in BSL 3 (Bio-Safety Level 3) to consist of full gown-up and HEPA filter PAPR breathing devices.
• Select agent culture, DFA, gamma phage analysis, TRF
• Performed DNA extractions and Real Time PCR testing on select agents.
• Implemented new Quality Control and testing worksheet documents.
Catholic Health System
Sister’s of Charity Hospital
2157 Main Street
Buffalo, NY 14214
10/06-2/07
Clinical Microbiology Technologist (Per Diem)
• High-volume sample set-up (receiving, plating, gram stains, TB processing)
• Reading of sample gram stains, TB direct/concentrate smears
• Analyzing positive blood cultures and TB smears
• CDiff toxin and kit testing for ova & parasites
Marshfield Clinic (Rapid Temps Travel Tech Agency)
1000 N Oak Ave
Marshfield, WI 54449
10/17/05-1/2/06
Clinical Microbiologist (Travel Tech Temp-Rapid Temps)
• Performed high-volume gram stains for human and vet samples
• Set-up cultures for human and vet samples
• Customer Service; phone calls, research, and investigate culture status
Roswell Park Cancer Institute
Elm & Carlton, Buffalo NY 14263
2/99-7/2/05
Clinical Laboratory Scientist (Medical Technologist)
Microbiology/Clinical Endocrinology Chemistry
• Maintained excellent rapport with the Head of Infection Control Physician per culture consultations and dedication to patient care.
• Analysis of biologics through the use of instrumentation and judgment in the areas of infection and antibiotic testing. Involved in reading cultures for pathogens, utilizing instrumentation for confirmatory identification and therapy results, virology via fluorescent microscopy and antigen/antibody/staining techniques, mold/yeast testing, endocrinology analyte measurements, therapeutic drug monitoring, metabolic chemistry testing via analyzers and microscope analysis.
• Supervisory skills and Lead Tech responsibilities in regard to decision making, troubleshooting, effective time management, prioritizing, research, SOP writing, management of QC, tables, charts, and computer programs of lab, extensive experience in independent work and excel in organizing project development/teamwork.
• Teaching to consist of Medical Residents, Infection Control consults, University students, high school, and involvement in career fairs. Also, teaching other Techs in Microbiology and instrumentation.
• Environment of multitasking, organizational skills, phone work, computer efficiency to include lab based programs, knowledge of MS Office programs.
• Knowledge and experience with lab regulatory agencies, OSHA, MSDS, SOP writing, lab-related cost management, and have extensive background with validations, comparison studies, and new testing implementation.
• Biological/Biohazard Materials Shipper Certified
• Worked in Specimen Processing/Processing Department for one year prior to Tech work. Performed extensive work problem solving reference lab samples in high-volume work setting, and mediating departmental groups.
American Pharmaceutical Partners
3159 Staley Road, Grand Island NY 14072
3/98-2/99
Microbiology QC Tech
• Assisted in Research Scientist experiments with validations
• Batch sterility testing of manufactured pharmaceutical products
• Particle count & spore testing
• Endotoxin testing; LAL (Limulus Amoebocyte Lysate assay-endpoint/kinetics)
• Water sterility testing
• Investigation protocol, Quality Assurance, SOP updates
• GMP knowledge (Good Manufacturing Practice) & GCP (Good Clinical Practice)-introductory background
• Clinical trial phase theory-introductory background
Quest Diagnostics
1 Sylvan Road, Amherst NY 14228
10/88-9/97
Clinical Laboratory Scientist (Medical Technologist)
• Automated Clinical Chemistry, Hematology, Endocrinology Analysis
• ELISA testing
• Quality Control evaluation
• SOP writing
• Quality Assurance-process to end result phase lab audits
• Specimen Processing Reference testing preparation experience
Erie Community College-North and South Campus
Main & Youngs
Williamsville NY 14220
6/87-5/90
Clinical Lab Work Study-Medical Technology Dept (Lab Assistant)
Admissions Dept Work Study
• Lab Assistant: Preparing labs for students with reagents, supplies, bacteria plate set-up, cleaning, computer lesson plan work
• Admissions Dept: Secretarial duties to include phones, filing, appointments, walk-in assistance with college information, records
Education:
University of New York at Buffalo, Buffalo NY
B.S. Clinical Lab Science (MT, ASCP-Technologist) 1996
• American Society of Clinical Pathologists Certified
• Emphasis on Chemistry, Biology, Anatomy & Physiology, Pathology, Hematology, Immunology, Microbiology, Lab Management & Teaching
Erie Community College, Buffalo NY
A.A.S. Clinical Lab Science (MLT, ASCP-Technician) 1990
Certification/Licensure:
• NYS licensure-009155 (registered through 5/13)
• American Society of Clinical Pathologists (ASCP) MT #207979, 1996
Other:
• Creative Writing
• Technical/Medical/Scientific Writing interests
• Travel Writing/International travel interests
• Computer troubleshooting, installation, programming, and maintenance
• Marketing experience from personal writing business
• Clinical Research Associate course with Kriger Research to include knowledge of IRB, informed consent, and other regulated procedures governing new drug applications and clinical trials I-IV.
References:
Patrick Booth, Lab Manager Sisters of Charity Hospital, 716-***-****
Connie Bauer, VP Lab Services Catholic Health System, eym5mx@r.postjobfree.com
Debra Johnson, Lab Director Outer Banks Hospital, eym5mx@r.postjobfree.com
• Dr Scott Zimmerman, Laboratory Director, Erie County Public Health Lab
716-***-****)/eym5mx@r.postjobfree.com)
• Dr. Segal, Infection Control Dr, Roswell Park Cancer Institute
716-***-****)/eym5mx@r.postjobfree.com)
• Eileen Duman, Lab Director, Roswell Park Cancer Research Center
716-***-****)/eym5mx@r.postjobfree.com
Contact this candidate