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Quality Control Tech II

Location:
Decatur, Georgia, United States
Posted:
December 03, 2018

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Resume:

FREDA CHARISSE LYDE

**** ********** ******

Decatur, Georgia 30035

ac7u4e@r.postjobfree.com

470-***-**** or 404-***-****

SUMMARY OF QUALIFICATIONS

Proficient with bacterial, viral, and tissue culture growth and maintenance.

Experienced with a range of techniques for microbial analysis and identification; including ELISA, Viral and Toxin Neutralization Assays, SDS-Page, Flow Cytometry and PCR (conventional and Real- Time).

Experienced with bacterial culture and Eukaryotic cell cultures through various college courses and their adjoining

labs such as Biology, Microbiology, and Animal Biology.

Computer literate, with experience using Access, StarLIMS, and Excel.

Experienced with laboratory processes and a team oriented approach to meet and achieve time sensitive

deadlines for individual projects.

SKILLS/EQUIPMENT

Data interpretation and presentation, gel electrophoresis, agarose gels, preparation of reagents, PCR, ELISA,

incubators, autoclaves, plate washers, coating antigen adsorption plates, cell culture techniques, slide

agglutination techniques, pipettes, Dynex reader, specimen management, catalogue and long-term storage and organization of large number of isolates and strains, infectious disease testing, ABO grouping, Rh typing, immunohematology blood bank procedures, chemical and biological analysis on wastewater, cell counting,

hot water baths, centrifuges (micro-centrifuge and ultracentrifuge), gel filtration, separation by ion exchange, spectrophotometer, pH meter, electron microscope, phase contrast microscope, dark field microscopy, aseptic venipuncture, aseptic surgical techniques, BSL II hoods, Stay-Clean hoods, sling psychrometer, animal

handling experience, handling of potentially infectious human tissue/specimens, use of micro-surgery

instruments, instrument sterility, disposing of biohazard materials, handling of caustic/toxic material,

viscosity testing, microbial swabbing, photographic equipment, hemocytometer, flow cytometer, King Fisher,

King Fisher 96, DNA Sequence, Magna-Pure Compact, Magna Pure Compact-96, thermocycler, E-gel,

Labchip GX, nanodropper, 7500 Fast DX Real Time PCR System, 3130X Genetic Analyzer; SDS Page;

Western Blot, FC500 flow cytometer

EMPLOYMENT HISTORY

Quality Control Associate II (Dendreon) (October 22, 2012- May 31, 2018)

Accountable for testing of Dendreon’s products in accordance with appropriate regulatory, corporate and

scientific guidelines.

Assist with product testing, raw material testing and general laboratory maintenance.

Perform, as assigned, in-process and final product testing of Dendreon products.

Receive and maintain test samples, reagents, and reference standards used in the laboratory per approved

procedures.

Perform flow cytometry to determine cellular composition and potency of in-process samples and final

product samples manufactured at Dendron through staining, acquisition, optimization of Quantibrite beads,

optimization of stained samples, acquisition and analysis of Quantibrite beads, acquisition and analysis of

stained samples, and input and review of data put into LIMS.

Perform Endotoxin testing on final products prior to release using Kinetic-QCL-Kinetic-Chromagenic Assay

used to measure the reaction of endotoxins with LAL reagent.

Prepare slides for Gram Stain testing, both manual and Previcolor Gram Stain, to observe any microbial

contamination of cell therapy products prior to release.

Use an Automated Beckman/Coulter AcT* 5 diff Cap Pierce Automated Hematology Analyzer to determine

the complete blood count (CBC) for active cellular immunotherapy (ACI) samples.

Perform manual procedure to determine percent viability of in-process and final product samples using Trypan

Blue Exclusion Method.

Perform ELISA (coated strips using ELISA plate coating antibody) testing to confirm the identity of

Sipuleucel-T by detecting the presence of the PA2024 Fusion protein.

Use Cellometer Vision Automated Cell Counter for in-process and final product testing on clinical samples

known as DN24-02 using two fluorescent dyes, Acridine Orange (AO) and Propidium Iodide (PI), to determine

the percent viability of the samples.

Perform Endotixin DN24 testing on clinical active cellular immunotherapy final products prior to release using

Pryogent 5000 LAL.

Perform ELISA DN24 testing on clinical active cellular immunotherapy final products prior to release to confirm

the presence of BA7072 (recombinant antigen) fusion protein.

Prepare slides and perform a manual leukocyte differential on clinical samples to determine the percentage

of granulocytes (neutrophils, eosinophils, and basophils) among the existing white blood cell population in

clinical products using Bovine Serum Albumin and CAMCO Quick Stain II.

Qualified to write Laboratory Investigation Reports (LIR’s) on assay validity failures in the lab and perform

investigations to write Environment Reports (ER’s) when there is a failure or recall involving the active cellular immunotherapy (ACI) products.

Cross-trained in the Microbiology Laboratory to evaluate plates and perform plate counting.

Perform and pass proficiency testing of all assays assigned in the Bioassay laboratory.

Perform routine equipment maintenance.

Adhere to good documentation practices to ensure data integrity and traceability.

Communicate with Corporate QC and ensure implementation of harmonized laboratory control systems in the

Union City Bioassay Laboratory.

Experience in cGMP/FDA regulated industry.

Proficient in MS Office applications.

Laboratory Technician, Center for Disease Control and Prevention (P3S Corp) (November 7, 2011-

October 19, 2012)

Provide scientific and technical support services to CDC and grantees in the implementation of molecular

typing methods of B. pertussis isolated during pertussis domestic and international surveillance programs

and outbreak response.

Provide technical support for assay development standardization and validation.

Support development and validation of diagnostics tests, molecular typing systems, and laboratory diagnosis

support during outbreak responses.

Perform culture, serological testing and PCR laboratory testing for laboratory diagnosis of Bordetella pertussis

on clinical specimens and isolates.

Participate in activities to support the design, development and implementation of laboratory methods

and activities to improve B. pertussis detection and work with the pertussis and diphtheria laboratory

(PDL) team to ensure successful progress in the work analysis and meeting milestones for all identified activities.

Design, develop and maintain standard operating procedures for consolidated DNA sequencing and molecular

typing project activities. The molecular typing methods include: MLST, MLVA and PFGE.

Communicate with team lead weekly and internal CDC staff daily: show isolates typing results.

Track isolates shipment and testing. Document isolates shipped and tested at CDC.

Manage and enter project data, develop progress reports, present and communicate project progress and participate in data analysis and reporting of results.

Perform quality control testing on new enzymes, primers and probes.

Culture and extracted Positive Controls using Qiagen One Kit.

Perform oxidase test, slide agglutination, boil preps and PCR to prepare and freeze cultured beads of different

Bordetella isolates.

Passed proficiency/competency tests.

Perform comparison study between different enzymes, Gene Expression and Quanta, using PCR and known results from other laboratories.

Assist in rewriting technical protocols related to the use of culture, real-time PCR and serological methods for

laboratory diagnosis of pertussis.

Documentation of daily work with good laboratory practice.

Perform duties in compliance with federal quality systems.

Laboratory Technician, Center for Disease Control and Prevention (LHI) (November 30, 2009-September 30, 2011)

Diagnosis of rotavirus in samples by EIA using commercial testing kits for positive results for rotavirus.

Genotyping and molecular characterization of rotaviruses from samples by methods based on polymerase chain

reaction and nucleotide sequencing.

Perform detection of Rotavirus by Real-time PCR.

Extraction of nucleic acids from samples using King Fisher, King Fisher 96, HiBind RNA Mini Column for RNA extraction from stool, and automated extractor instruments such as the Magna Pure and Magna Pure Compact 96.

Perform testing for genotyping samples positive for Rotavirus using Qiagen One Step and Second Round

Amplification for Specific Primers.

Perform extraction of DNA from samples for sequencing using gel electrophoresis and E-gel technique.

Clean DNA extraction using QIA-quick Gel Extraction Kit or Min-Elute PCR Purification technique.

Perform purification of cycle sequencing product using BioMag Carboxyl Beads.

Perform cycle sequence of DNA product using Genetic Analyzer.

Perform computer based analysis of rotavirus genes through knowledge of techniques for analyzing rotavirus

genes and genotypes and performing evolutionary analysis, sequence alignments, and genetic distances

comparisons.

Prepare charts and posters to help write periodic reports on enhanced surveillance activities.

Perform Real-time RT-PCR with rTth on samples to test whether they are positive or negative for Rotavirus.

Prepare and wrote protocol on how to Prepare G and P Ladders, ladder controls used for genotyping samples

using LabChip and/or gel electrophoresis.

Prepare SDS page to test by Western blot samples that could not test by conventional PCR.

Maintain laboratory equipment-perform preventive maintenance, temperature charts, and autoclave.

Gave presentations on performance and results from data on samples tested for rotavirus.

Gave presentation on chosen article in Journal Club.

Assist in the making and aliquots of controls and primers used in the lab.

Entered all information on samples tested into database system-Bionumerics.

Performed and passed proficiency testing according to Rotavirus protocol.

Tested sample panel by EIA to be used for proficiency testing in the lab.

Performed and passed proficiency testing according to Rotavirus protocol.

Worked on comparison testing of samples using Rotaclone and Prospect.

Worked on Diaper study comparing samples stored in Rotaclone diluents, PBS, and Earle’s BSS (1X).

Complied with CLIA and CDC policies, regulations, safety, and procedures.

Microbiologist, Center for Disease Control and Prevention (AREF) (May 6, 2003-June 30, 2009)

Conducted research on the only Anthrax Vaccine Clinical Trial in the United States.

Performed serological testing of animal and human samples from pre-clinical and human clinical trials of anthrax vaccines using ELISA.

Performed ELISA in establishing ranges for National Reference serum for human and macaque sera.

Performed toxin neutralization assay (TNA) to measure and quantify the functional ability of anti-AVA

antiserum to neutralize B. anthraces lethal toxin activity in vitro cytotoxicity assay.

Performed cell count using hemocytometer to seed plants for TNA assay.

Developed assays for sensitivity and specificity.

Assisted in organizing and devising a plan in receiving, aliquot, and preparing incoming samples, using

STARLIMS, for serological testing.

Influential in identifying problems associated with STARLIMS and requesting the necessary upgrades to the

Laboratory Information System.

Organized and prepare incoming samples, using STARLIMS, for serological testing.

Developed and implemented an SSP for logging samples out of specimen management, storage for testing in

ELISA, catalogue freezers, and disposing of samples when testing is finished.

Implemented ideas, which help to streamline and organize workflow in the ELISA lab to aid in productivity.

Performed data analysis of ELISA plates using NAL, ELISA for Windows, and SAS.

Made reagents essential to performing ELISA procedures.

Assisted in making label templates for reagents, which helped create uniformity and consistency when labeling

reagents.

Read plates on Dynex plate reader.

Checked out samples from Specimen Management team and maintain chain of custody.

Aliquoted test samples and reference serum for testing.

Passed proficiency testing according to ELISA SSP.

Performed ELISA procedure according to SSP with very low failure rate.

Performed ELISA testing on human, macaque, and rabbit sera with a very high passing rate.

Performed maintenance on lab equipment.

Identified pertinent equipment needed in the ELISA laboratory.

Ordered lab equipment, reagents, and supplies needed for the ELISA lab.

Familiarized new models of laboratory equipment and ordered them for the laboratory to aid in productivity.

Established and maintain relationship with key vendors.

Scheduled vendor based training sessions on new and existing lab equipment.

Maintained laboratory equipment (temperature charts, maintenance charts, etc.).

Stocked laboratory when supplies were needed.

Wrote SSPs on proper maintenance of lab equipment.

Developed quality assurance forms to track maintenance on equipment and to report problems that deviate from

the protocol.

Performed IQ, OQ, PQ on equipment.

Negotiated quotes with vendors and reduce overall equipment cost to the branch.

Developed Quality Management System.

Assisted in qualification of reagents.

Trained employees on the ELISA procedure.

Coordinated research projects.

Assisted in the qualification of the Dynex reader.

Assist in writing protocols.

Developed new concepts, techniques, material, or products related to serological assessment of the immune

response to anthrax vaccines.

Communicated with supervisor and other team members on methods, progress, and results of testing.

Conducted experiments following, SOP, GLP and OSHA guidelines.

Assisted with team building exercises.

Helped organize holiday parties.

Participated and assist with monthly birthday luncheons.

Laboratory Technician, American Red Cross (March 1999 –July 21, 2003)

Provided infectious disease testing, ABO grouping, Rh typing, and related laboratory services using standardized equipment, computer software, and operating procedures.

Performed manual and automated procedures, enzyme immunoassay, and/or immunohematology blood bank

procedures.

Maintained knowledge of all procedures necessary to perform work, discern results, and generate test results.

Performed quality control functions and daily, weekly, and monthly maintenance, and followed Good

Manufacturing Practices (cGMP).

Maintained neat and accurate records, recognized, and reported discrepant results.

Reviewed test results and validated or invalidated runs.

Performed antibody testing using the Summit (screening cells, anti IgG, check cells).

Performed ABO grouping, Rh typing, TP (syphilis) and CMV testing using the Olympus.

Used specific reagents, performed manual ABO grouping and Rh typing.

Used RPR technique to manually test for syphilis and CMV.

Performed ALT and cholesterol testing using the Hitachi.

Participated and assisted in training new employees by serving as a preceptor or instructor.

Ensured that performance and productivity standards were met.

Performed tests related to ongoing projects and evaluations when requested.

Complied with all the State, Federal regulations, National Red Cross Blood Service procedures, the NTL policies,

and laboratory safety requirements.

Assisted Management in Error and Accident investigation and helped implement appropriate corrective action.

Provided on-call coverage.

Environmental Water Technician, Fulton County: Public Works Department (March 2002-February 2003)

Collected and analyzed water and wastewater samples including field and laboratory testing.

Performed a variety of chemical and biological analysis on wastewater, water samples, and samples from

industries to determine various levels of specific contaminants to determine if samples exceeded compliance standards of various regulations.

Interpreted and recorded findings.

Prepared chain of custody and calibration for sampling and maintaining instruments and records.

Operated and maintained a variety of analytical laboratory equipment.

Performed and insured quality control and quality assurance as prescribed by standard methods of EPD and EPA agencies.

Compiled records and data for accurate record keeping as recommended by State and Federal government.

Performed site inspection of industrial facilities to investigate and monitor facilities environmental health

hazardous and wastewater discharge.

Located sewage spills that are in excess of established amounts.

Coordinated meetings with County inspectors and contractors to perform testing and sampling of new waste

water lines.

Collected samples for analyses from various sources.

Ensured that samples collected are delivered to appropriate laboratories following established chain of custody.

Laboratory Technician, Fulton County Health Department (May 1992-May 1995 & June 2001-March 2002)

Performed microscopic examinations by using correct procedure for preparation of specimens (Gram stains,

wet mounts).

Read slides collected from patients attending the STD clinic for trichimonasis, clue cells (bacterial vaginosis),

yeast, non-gonococcus urethritis (NGU), and Neisseria gonorrhea.

Performed sterile cell culture techniques in the isolation and identification of Neisseria gonorrhea using Gram

stain, oxidase test, microscopy, and beta lactamase test.

Performed dark field microscopy for Treponema palladium.

Obtained human specimen by using proper techniques in performing venipuncture.

Performed serological tests (RPR) for syphilis (qualitative and quantitative) and RPR on females to test for

Rubella.

Performed urinalysis (chemical, bacteriological and microscopic).

Prepared and supervised the preparation of all specimens and necessary reagent.

Trained new personnel on performing microscopic procedures.

Organized and maintained the lab and lab supplies needed to perform tests.

Disposed of waste and waste material used in the lab.

Performed scheduled maintenance of STD laboratory equipment (microscope, dyes for Gram stain, etc.).

Complied with methods established by supervisor for quality control in the laboratory.

Documented and reported test results performed in the lab.

Signed and filed laboratory report forms on those results.

Maintained different logbooks, prepared protocols for training in the laboratory, and ordered laboratory

equipment.

Prepared protocols for training procedure and in documenting lab results.

Lead Laboratory Animal Technician, Priority One Services (October 1995-July 1998)

Provided husbandry/care to researcher animals, monitor their environment and observe their health status on

a daily basis.

Followed guidelines in recording observations on animal charts.

Transported animals from their home cages to labs within the building.

Obtained blood samples and made blood smears.

Administered drugs/medications as directed/requested.

Ensured proper veterinary care and treatment for animals maintained.

Feed special diets or withheld food as requested/directed.

Assisted in the handling and restraint for examination or dosing and determination of animal body weight.

Cleaned/sanitized caging rooms and equipment and participated in environmental monitoring.

Monitored the performance of all subordinate personnel, provided counseling or additional training/supervision

as needed.

Assured that adequate inventories of items routinely used are available.

Identified potential problem areas with personnel, equipment or facilities.

Scheduled and performed established daily work routines.

Assured that records, logbooks, and other project records were appropriately and contemporaneously maintained.

Scheduled, performed, and documented activities necessary to accomplish work assignments.

Established liaison/communication with research personnel to facilitate responsiveness.

Complied with CDC policies, regulations, safety, and procedures.

Maintained a current knowledge of proposed laws, regulations, and guidelines affecting the care and use of

laboratory animals.

Assisted in the receipt of animals, supplies, feed and bedding.

Performed monthly air- flow tests, spore and vacuum tests using pH monitors, Hygrometers, biological indicators,

and thermometers.

Performed routine endo- and ecto- parasite examination on animals for pre-operative patients (needles, syringes,

calculator, fecalizers, and microscopes.

Followed SOP in processing serum for shipping (centrifuge, serum separation, and heat inactivation).

Determined appropriate vaccination and vaccination schedules for each species of large animal (quarterly TB

Testing and blood collection of nonhuman primate colony).

Performed aseptic venipuncture and aseptic surgical techniques for pre-operative patients (calculated anesthetic

dosages and administered via IM, IP, IV, S.C., and inhalation routes).

Performed euthanasia of animals in accordance with the AVMA Panel on Euthanasia, per veterinarian and/or

investigator.

TRAINING

STARLIMS

GLP training

Proper Use of Biological Safety Cabinets

Blood borne Pathogens

Safety Training II and I

Hazardous Chemical Waste Management

Security Awareness

Teambuilding

Homeland Security Exercises and Evaluation Program

Biological Spill Response

CERTIFICATES

Certified Laboratory Animal Technician (AALAS)

Certified Medical Laboratory Technician (AMT)

ISO 9001: 2000 Internal Quality System Auditor

COMPUTER PROGRAMS

STARLIMS

ELISA for Windows (NAL)

SAS

Microsoft Access and Excel 2003

Certification for Level 1 Training on Assay Design and Optimization

Bionumerics

PUBLICATIONS

Bacillus-ACT 2007

Bacillus anthracis, B. cereus and B. Thuringiensis Internal Conference

June 17-21, 2007, Oslo, Norway

Semenova, V; Steward-Clark, E; Fox, S; Brawner, M; Lyde, F; Thompson, R; Brown, N; Schmidt, D; Soroka, S;

Schiffer, J; Quinn, CP. Partial Validation of Anti-PA IgG Enzyme Linked Immunosorbent Assay (ELISA) for

Detection of Bacillus anthracis PA-Specific IgG in Human with Standard Reference serum AVR801. Abstract

120, p. 89.

46th Interscience Conference on Antimicrobial Agents and Chemotherapy, (ICAAC), 2006,

September 27-30, 2006, San Francisco, CA, USA

Schmidt, DS; Semenova, VA; Steward-Clark, E; Ballard, M; Brown, N; Lyde, F; Thompson, R; Fox, S; Davis, L;

Nuzum, E; Hewitt, J; Johnson, S; White, J; Wilkins, P; Quinn, CP, The Characterization of Rhesus Macaque

(Macaca mulatta) Anti-Protective Antigen (PA) Standard Reference, Quality Control and Proficiency Test Sera

Reagents.

AWARDS

August 11, 2010 Certificate of Appreciaton for Excellence in Program Delivery in the American Reinvestment

and Recovery Act 317 Initiative Presented by Anne Schuchat, M.D., Director, National Center for Immunization

and Respiratory Diseases

March 7, 2008 Certificate of Achievement for Excellence in Innovation/Exceptional Support Work in AVRP Presented by Nancy Messonnier, M.D., Branch Chief, MVPDB Division of Bacterial Diseases, NCIRD

March 7, 2008 Certificate of Achievement for Excellence in Innovation/Partners in Public Health Improvement

Presented by Nancy Messonnier, M.D., Branch Chief, MVPDB Division of Bacterial Diseases, NCIRD

May 1, 2006 Honor Award Certificate In appreciation of contributions and participation in the Honor Awards

Programs NCID Recognition Awards Ceremony National Center for Infectious Diseases Presented by Rima

Khabbaz, M.D., Director, National Center for Infectious Diseases

August 25, 2005 Honor Award Certificate for Partners in Public Health Improvement National Center for

Infectious Diseases Presented by Anne Schuchat, M.D., Director, National Center for Infectious Diseases

July 22, 2004 CDC and ATSDR Group Honor Award in Partners in Public Health Improvement for the Anthrax

Vaccine Research Program Team submitted by the National Center for Infectious Diseases Presented by Julie

Louise Gerberding, M.D., M.P.H., Director, CDC Administrator, ATSDR

June 1, 2004 National Center for Infectious Diseases Honor Award Certificate In appreciation of contributions

and participation in the Honor Awards Program /NCID Recognition Awards Ceremony Presented by James M.

Hughes M.D., Director, National Center for Infectious Diseases

April 30, 2004 Certificate of Achievement Group Honor Award Microbial Pathogenesis and Immune Response Laboratory for dedicated contribution to completion of samples tested for the anthrax vaccine human clinical

trial interim analysis Presented by James M. Hughes M.D., Director, National Center for Infectious Diseases

EDUCATION

Biology/Chemistry Bachelor of Science

Georgia State University- August 1992

REFERENCES

Shakena Day

DENDREON

Quality Assurance Tech II

ac7u4e@r.postjobfree.com

850-***-****

Monte Martin (CDC)

CDC/OID/NCIRD

Microbiologist

ac7u4e@r.postjobfree.com

404-***-****

Rashi Gautam (Atlanta Research and Education Foundation)

CDC/OID/NCIRD

Microbiologist

ac7u4e@r.postjobfree.com

404-***-****

Michael Bowen (Supervisor of Rotavirus Surveillance Team)

CDC/OID/NCIRD

Microbiologist/Team Leader

ac7u4e@r.postjobfree.com

404-***-****

Vera Semenova (CDC)

CDC/OID/NCIRD

Microbiologist

ac7u4e@r.postjobfree.com

404-***-****

Evelene Steward-Clark (CDC)

CDC/OID/NCIRD

Research Microbiologist

ac7u4e@r.postjobfree.com

404-***-****



Contact this candidate