Training Quality Control

Summary of Qualifications

Nine years of teaching and laboratory research experience, with expertise including start-up laboratory management, molecular biology research techniques, training, and supervision.

Professional Experience

Bioassay Quality Control Associate II (contractor)

June 2011- Present

Dendreon Corporation Union City, GA

•Perform quality analysis of in-process and final immunotherapy products using FDA compliant assays such as: Complete Blood Count, cell viability, endotoxin, ELISA, flow cytometry, and Gram stain.

•Experienced with ISO standards, Good Laboratory Practices, and Good Manufacturing Practices.

•Manage test samples, reagents, and materials used in the laboratory per approved procedures.

•Receive samples, enter data into LIMS, and perform peer review of data entry for errors.

•Perform routine laboratory equipment maintenance.

•Audit laboratory equipment logbooks for compliance.

•Revise and update standard operating procedures.

•Perform testing in support of test method transfer and validation studies.

•Assist with training of QC personnel.

Lead Biological Scientist, BioWatch Program

August 2008- February 2011

A-TEK, Inc./Georgia Public Health Laboratory

Decatur, GA

•Received, extracted, and performed real-time PCR analysis of environmental surveillance samples, 365 days/yr.

•Supervised staff and scheduled daily coverage for BioWatch testing procedures.

•Performed quarterly competency assessments and documentation of staff deficiencies, as necessary.

•Resolved employee issues and maintained good employee relations.

•Developed and maintained laboratory Continuity of Operations Plan (COOP).

•Ensured staff compliance with emergency evacuation, biosafety, and biosecurity training requirements.

•Increased staff occupational awareness by providing access to Select Agent training modules.

•Documented and encouraged staff participation in relevant trainings to increase knowledge, skills, and abilities.

•Increased laboratory emergency testing capacity by hiring and training emergency support personnel.

•Updated and maintained laboratory Standard Operating Procedures.

•Performed troubleshooting for technical laboratory issues, including instrumentation fluctuations and tracking data trends.

•Established and maintained relationships with local, state, and federal BioWatch program partners.

•Managed inventory and submitted weekly reports.

•Submitted daily results using a CDC-established LIMS network.

•Maintained QA/QC documentation records and chain of custody procedures.

•Provided back-up H1N1 Influenza testing services and support for testing of other emergency specimens.

•Laboratory representative and contributor to the BioWatch Advisory Committee for the state of Georgia.

•Attended national meetings relevant to all-hazards preparedness, including bioterrorism and emergency management procedures.

Clinical Laboratory Technologist

March 2007- February 2011

Georgia Public Health Laboratory

Decatur, GA

•Bioterrorism and Emergency Response position with Select Agent clearance.

•Performed real-time PCR detection of bio-threat agents in accordance with Laboratory Response Network (LRN) guidelines.

•Provided 24 hour preparedness coverage for emergency white powder testing purposes.

•Performed daily clinical sample processing in BSL-2/BSL-3 suites using aseptic technique.

•Provided routine testing of outbreak specimens from Georgia hospitals and laboratories, such as Influenza and Norovirus.

•Validated platforms, protocols, and reagents, as well as performed weekly and monthly QC duties.

•Participated in the set-up and demonstration aspects of GPHL-sponsored trainings with LRN Sentinel laboratory personnel.

•Performed and reported results of validation studies.

Laboratory Technician III

September 2004- March 2007

Georgia State University

Atlanta, GA

•Managed all activities related to budgeting and purchasing toward the success of a start-up laboratory.

•Research involved complex antibody/receptor interactions and their subsequent affects on the immune response.

•Implementation of new research protocols

•Training and supervision of undergraduate students.

•Utilized a wide array of molecular biology research techniques, including Immunoprecipitation and real-time PCR.

•Planning and execution of weekly experiments.

Research Technician II

May 2002- September 2004

Georgia Institute of Technology

Atlanta, GA

•Advanced scientist position in the Institute for Bioengineering and Biosciences.

•Research focused on steroid hormone receptor influence on bone and cartilage formation.

•Maintained current molecular biology protocols and trained students in tissue culture techniques.

Education

Master of Science, Biology

August 1999 – May 2001

Georgia State University Atlanta, GA

Bachelor of Science, Biology

August 1993- May 1997

Morehouse College

Atlanta, GA

Skills

Personal:

•Highly organized and dedicated with a positive attitude.

•Competent team player with an excellent work ethic.

•Strong quantitative and qualitative analytical skills.

•Ability to handle multiple assignments under pressure and consistently meet deadlines.

•Excellent written, oral, and interpersonal communication skills.

•Skilled at writing protocols and reviewing data reports.

Computer:

•Advanced proficiency in Microsoft Office Suites.

•Advanced proficiency in ABI instrumentation software.

Laboratory:

•Clinical Laboratory Specialist in Molecular Biology Certification (CLSpMB/ASCP).

•Expertise on ABI 7000, ABI 7500, LightCycler, iCycler, ABI 3100, and Luminex/Bioplex platforms.

•Facilitator – “BioWatch: Laboratories gone Green” roundtable discussion (BW National Workshop – Milwaukee, WI 2010)

•Participant - Agents of Bioterrorism: LRN Rapid Methods Update Course (CDC - Atlanta, GA 2008)

•Participant - Agents of Bioterrorism: LRN Conventional Methods Course (MDH - St. Paul, MN 2007)

Community Activities:

•Omega Psi Phi Fraternity, Inc

•Tony Elementary School Tutoring Program

•Dekalb Clean and Beautiful

References

Available upon request

Contact this candidate