Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000,

Detail-oriented, self-motivated, reliable professional with the ability to take ownership of all responsibilities. with
dedication with Good manufacturing practices, quality Assurance and control, seeking an opportunity to become part
of a dynamic team by performing accurately and complying with all protocol and standards.

  • Good Manufacturing Practices (cGMP)
  • MS Word, Excel, and PowerPoint
  • Adobe acrobat Sign
  • Quality assurance procedures
  • Equipment knowledge and handling
  • Attention to detail
  • Regulatory compliance
  • Data Entry
  • Team Player
  • PCR knowledge
  • Quick learning skills
  • MLPA Test method,DNA Microarray Technology
  • Good Aseptic techniques
  • Regulatory Affairs
  • Documentations
02/2022 to Current Quality Assurance Specialist Bae Systems | Hanscom Air Force Base, MA,
  • Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
  • Manage and support the Change control(DCN) process and activities throughout the approval and release process.
  • Administer the documents control function to ensure all controlled documents are approved and implemented according to procedure.
  • Maintain the change control program to capture changes with equipment,processes or methods.
  • Manage equipment calibration program and any associated SOPs.
  • Maintain supplier files and current approved suppliers list.
  • participate in quality audits.
  • Perform acceptance activities to ensure products meets specifications.
  • Maintain employees training files,review and audit employee training files as needed
  • Develop and conduct GMP and QMS employee training as needed.
  • Maintain equipment calibration,inspection,maintenance procedure(s) to ensure that the system(s) are compliant.
  • Review Device History Records(DHR)and data forms for completeness and accuracy.
10/2019 to 02/2022 Clinical Laboratory Scientist II Sutter Health | San Carlos, CA,
  • Perform pre-analytical and post-analytical testing, Revise and Adhere to Standard Operating Procedures (SOPs).
  • Adhere to FDA regulations that governs the facility with current good manufacturing practice (cGMP).
  • Able to design,analyze and interpret controlled experiments to facilitate assay development
  • Thorough knowledge of and experience in general molecular biology techniques with aseptic and general microbiology.
  • Managing and maintaining calibration records as well as coordinating calibrations. Maintain equipment logs and inventory
  • Prepare Work Orders,review work order for accuracy and completion
    Coordinate Manufacturing needs with Quality Control
  • Cooperate with coworkers within an organized team environment and work with minimal supervision
  • Effectively communicate project status to supervisor peer and other staff
  • Manage time effectively to complete assignments in the expected time frame. Perform work assignments accurately timely and safely
  • Maintained physical lab equipment, detecting malfunctions and troubleshooting to ensure optimum service.
11/2018 to 05/2019 Biopharmaceutical Manufacturing Associate Eurofins Scient. | Mebane, NC,
  • Downstream Process: Operate and Maintain Chromatography Equipment and Purification Filtration Systems,
  • Complete and Review batch production records to ensure cGMP documentation practices are followed and information entered is complete and accurate.
  • Using technical expertise to remove parts from automated systems for sanitization.
  • Responsible for taking samples to ensure product integrity
  • Adhere to FDA regulations that governs the facility with current good manufacturing practice (cGMP)
  • Adhere to Standard Operating Procedures (SOPs)
03/2016 to 07/2018 Microarray Technologist Johns Hopkins Bayview Medical Center | Baltimore, MD,
  • Specimens processing for analysis and establish proper chronological priorities for Genetic testing
  • Performing Multiplex Ligation dependent Probe assay by manual and Robotic setups .(Hamilton Microstars, ABI 3500 and 3730 Genetic analyzers
  • Properly calibrate and troubleshoot equipment to ensure precise test results
  • Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
  • Adhere to quality control policies including equipment maintenance, reagent preparation and testing, and general lab practices
  • Facilitate research into genetic causes of disease
  • Monitor test performance and document corrective actions
11/2013 to 02/2016 Tele-Interpreter Aon Hewitt | City, STATE,
  • Delivered real-time, accurate oral translations and interpretations for clients.
  • Follow ethical codes that protect the confidentiality of information (HIPAA)
  • Compile terminology and information to be used in translations, including technical terms such as those for legal and medical material.
  • Translate messages consecutively into specified languages, maintaining message content, context, and style.
  • Refer to materials, such as lexicons, and computerized terminology banks, as needed to ensure translation accuracy.
05/2009 to 09/2013 Pharmacy Technician Total Care Pharmacy | City, STATE,
  • Establish or maintain patient profiles, including lists of medications taken by individual patients
  • Receive written prescription or refill requests and verify that information is complete and accurate.
  • Answer telephones, responding to questions or requests Price
  • File prescriptions that have been filled
  • Call Doctors office to get new refills for diabetic patient.
Education and Training
Expected in 2016 Bachelor of Science | Biomedical Science Interamerican University of Puerto Rico, San Juan, PR GPA:
Expected in 2018 Master of Science | Regulatory science Johns Hopkins University, Baltimore, Maryland GPA:
  • Regulatory Affairs Online Program
  • Emphasis in the regulatory approval processes for global and domestic biotech products
  • Coursework in regulatory science, current good manufacturing, laboratory and clinical practices, as well as product development and manufacturing of products GPA: 3.6

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School Attended

  • Interamerican University of Puerto Rico
  • Johns Hopkins University

Job Titles Held:

  • Quality Assurance Specialist
  • Clinical Laboratory Scientist II
  • Biopharmaceutical Manufacturing Associate
  • Microarray Technologist
  • Tele-Interpreter
  • Pharmacy Technician


  • Bachelor of Science
  • Master of Science

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