Quality Manager Research Assistant
Resume:
BOBBY SHELVIN
DEER PARK, TEXAS 77536
********@*******.***
WORK EXPERIENCE
JAN.2016 TO TALECRIS PLASMA RESOURCES (GRIFOLS).
NOV.2016: QUALITY ASSOCIATE.
Primary Responsibilities:
Work with DMS system (patient data management).
Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual.
Perform a review of donor center records.
Perform weekly review of equipment incident logs.
Verification and release of sample shipment.
Perform Staging of plasma for shipment.
Inspection and release of incoming supplies.
Perform Weekly employee observations.
Participate in the Quality Assurance meetings and be part of the Quality Assurance team.
Assist the Center Quality Manager to ensure that cGMP regulations are followed.
Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met.
Performs a review of the documentation of unsuitable test results and the disposition of the associated units.
Perform daily donor record file review.
NOV. 2008 M.D. ANDERSON CANCER CENTER, HOUSTON, TEXAS.
TO AUGUST 2013 RESEARCH INVESTIGATOR.
PHASE I: CLINICAL LABORATORY RESPONSIBILITIES:
QA of laboratory source documents; perform query resolutions.
Attend Protocol initiation and ongoing review meetings.
Writing/revising laboratory SOP’S.
Performing consent verifications.
Responsible for creating and managing databases for clinical sample distributions.
PHASE 2: LABORATORY MANAGEMENT.
Assist in the preparation of monthly budget and expense reports.
Responsible for inventory monitoring and the dispensation of supplies to correct laboratory areas. This includes the preparation of biweekly ordering lists to ensure adequate supplies at all times.
Responsible for the maintenance and preparation of stock solutions.
Maintenance of tissue culture facility that includes decontamination of biosafety cabinets and incubators;
Responsible for equipment maintenance, calibration, and repair when necessary and ensure proper setup of new equipment. Also responsible for organization of laboratory equipment and space.
Maintain required training and safety records for laboratory personnel.
Ensure laboratory is in compliance with OSHA regulations in addition to ensuring laboratory passes inspections by institution’s Department Environmental Health and Safety, Radiation Safety (RBC, Radiation Biosafety Committee), Animal Care and Safety (AALAS, American Association for Laboratory Animal Science), IBC (Institutional Biosafety Committee), and IACUC (Institutional Animal Care and Use Committee).
DEC. 2007 M.D. ANDERSON CANCER CENTER, HOUSTON, TEXAS.
TO OCT. 2008 CLINICAL CELL THERAPY SPECIALIST.
RESPONSIBILITIES:
Perform cell manipulation/evaluation procedures following standard policies and procedures which include: Cryopreservation, cell product thaw/wash, cell infusion.
Responsible for aseptic handling of products at all steps to ensure the integrity, viability, and sterility of cellular products until final infusion to the patient.
Perform error-free calculations that include infusion doses, viabilities, dilutions, and cell concentrations.
Perform procedures and maintain accurate documentation in compliance with FDA, GLP, GMP, and GTP regulations.
Utilize various computer systems and databases to enter, retrieve, and compile data, complete patient laboratory records and prepare reports for review by Laboratory Directors, Quality Assurance personnel and physicians.
JULY 2001 M.D. ANDERSON CANCER CENTER, HOUSTON, TEXAS.
TO DEC. 2007 SENIOR RESEARCH ASSISTANT.
RESPONSIBILITIES:
Interactive research with M.D. investigating Chronic Lymphocytic Leukemia (CLL) involving B/T-cell isolation to determine their surface receptor profile's role in disease progression; additional prognostic markers evaluated were beta-2-microglobulin levels, myeloproliferative disease genetic marker expression, HLA-I expression, and Immunoglobulin V-gene mutational status.
Techniques employed: B/T-Cell Isolation, Tissue culture using HELA, CHO cell lines, B/T cell proliferation, Real Time Quantitative PCR/PCR, Recombinant protein production, and RNA/DNA isolation. Development of ELISA-based assays; Optimization of Immunoprecipitation/Western blots, FACS analysis.
Lab Management Activities:
Records maintenance: Material and Safety Data Sheets (MSDS), Product data sheets, stored patient samples; responsible for overseeing that equipment and instruments are in proper worker order; Ordering supplies; Responsible for ensuring that the lab is in compliance with current safety regulations.
04-2000- 06-2001 Research Technician III, Department of Pathology, Baylor College of Medicine.
07-1994- 01-1999 Scientist, Valentis, Inc.
07-1990- 07-1994 Research Assistant II – Aronex Pharmaceuticals.
11-1989- 07-1990 Research Assistant II, Department of Clinical Investigations, MD Anderson Cancer Center.
EDUCATION
B.S./M.S. Microbiology.
University of Louisiana, Lafayette, La
Contact this candidate