CAREER Pharmaceutical professional with 6+ years of cGMP experience in vaccine
SUMMARY manufacturing and bioanalytical and potency testing assays. Substantial
experience in reviewing cGMP batch records and documentation. Expertise in
lab analysis, data collection and data analysis.
Pursuing Global Pharmacovigilance: Benefit-Risk Management Certificate toward
MS in Regulatory Affairs and Quality Assurance.
Education
Temple UniversityFortwashington, Expected in Current ā āMaster of Science:Regulatory Affairs and Quality Assurance - GPA:
Gwynedd-mercy UniversityUpperwynedd, Expected in June 2009 ā āBachelor of Science:Medical Technology - GPA:Medical Technology
St. Christopher's Hospital for ChildrenPhiladelphia, PAExpected in ā āBachelor of Science:Clinical Laboratory Scientist - GPA:
Work History
Merck & Co - Bio-technician/ Lab technician City, STATE, 08/2010 - Current
Manage workflow and address shop floor concerns for all second shift MMR
technicians.
Optimized the sample pulling process.
Acted in accordance with cGMP guidelines to ensure strict adherence to domestic
and foreign regulations.
Document all work according to proper cGMP documentation practices and
perform review of manufacturing and laboratory testing documentation.
Maintain production and laboratory test records.
Assisted with updates to SOPs and SMFs to ensure ease of use.
Participated in design and implementation of training and developmental programs.
Maintain in-process checks and assist in developmental work pertaining to
production and laboratory test methods.
Perform all work duties via automated systems or manual operations in compliance
with safe operating procedures, company and government regulations and good
manufacturing practices.
Clean, assemble, operate, disassemble, maintain and troubleshoot equipment to
meet production and laboratory test schedules.
Dispose of process waste material as per departmental SOP and regulatory
guidelines.
Involved in streamlining production and laboratory areas.
Review real time and post process batch records and SAP transactions for
accuracy.
Perform computer analysis and data entry (SAP transactions, EBRs, PAS-X, LIMS,
MS Word, Excel and Power Point, Microsoft Outlook and analytical equipment
associated software packages).
Use of automated control system such as Delta V which governs the operation of
most production process equipment (particulate air counters, SMAs).
Highly experienced in aseptic technique for clean room environment.
Abington Memorial Hospital - Medical Technologist/ Generalist City, STATE, 05/2010 - 06/2011
Proficient in use of LVVS, HanDEL, LIMS, SAP and PAS-X platforms for
reviewing and entering process data.
Perform assays to calculate potency for MMR vaccines.
Processes performed includes
Temple University Hospital - Microbiology/ Medical Technologist City, STATE, 09/2009 - 08/2010
Responded to customer concerns with excellent communication and interpersonal
skills in a fast-paced environment.
Processed and received patient samples into Meditech.
Performed various assays for identification of pathogens to provide the best patient
care possible.
Philadelphia Public Health - Special Microbiology/ Medical Technologist City, STATE, 08/2009 - 02/2010
Processed and received patient samples.
Prepared reagent media necessary to perform high complexity tests.
Performed various assays in molecular lab (PFGE), TB lab and environmental lab.
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