LiveCareer-Resume
Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Summary
  • Regulatory Affairs Expert with background delivering regulatory support for pharmaceutical products and medical devices. Dedicated to collecting scientific data, interacting with clients and regulatory authorities and evaluating organizational practices to drive changes. Deep knowledge of pharmaceutical products and medical device regulatory requirements.
  • Proficient in TJC, OSHA, and FDA requirements for medical laboratory work. Effective at working as generalist to conduct all types of tests. Quality-focused and collaborative team player with reputation for accuracy and efficiency.
  • Knowledgeable about pharmaceutical products and medical device manufacturing practices, approval processes and regulations. Attentive and exacting with demonstrated success in handling domestic and international regulatory needs for diverse products. Systematic and practical with sound judgment, an analytical mindset and good problem-solving skills.
  • Hardworking and dedicated Regulatory Affairs Specialist successful at preparing and documenting regulatory paperwork. Tireless in maintaining current uClairerstanding of legal regulations in order to keep all products compliant. Bringing 2 years of pharmaceutical product and medical device regulatory knowledge, experience, and seeking a growth-oriented position.
Skills
  • Project management of pharmaceutical product life cycle
  • Specimen tracking
  • Bioinformatics
  • Techniques in Biotechnology
  • Global Business in Biotechnology
  • Preclinical and Clinical Research
  • Product Life Cycle
  • Regulation of Pharmaceuticals and Medical Devices
  • FDA Compliance
  • Practical Application of Biotechnology in Pharmaceutical and Medical Device Manufacturing and Regulations
  • Bio Practicals and Business in Biotechnology
  • Ethical and Societal Issues in Biotechnology Application
  • FDA Regulations and the Food, Drug, and Cosmetic (FD&C) Act
  • Laboratory experiments and investigations
  • Scientific programs
  • Life sciences
  • Computer skills
  • Sterilization techniques
  • Specimen analysis
  • Equipment testing and calibration
  • Experimental design
  • In-vitro transcription
  • Expert in data analysis
  • Western blotting
  • Microbiological techniques
  • DNA isolation expert
  • SOP development
  • Strategic planning
  • Agency inspection support
  • Project planning
  • Technical guidance
  • Labeling requirements
  • Aseptic techniques
  • Quality assurance and Quality control
  • PPE use
  • Training & Development
  • Inspections and audits
  • Product inspections
  • Laboratory computer systems
  • Sampling procedures
Education and Training
University Of Maryland Global Campus Adelphi, MD, Expected in 12/2020 Master of Science : Biotechnology And Regulatory Affairs - GPA :
  • 3.70 / 4.0 GPA
  • Thesis: FDA and EMA Approval process of Zimbiotic and TRACE Combination product for the Treatment of Breast Cancer. Zimbiotic and TRACE were Hypothetical Products
  • Completed professional development in Regulatory Affairs
  • Specialization in Regulatory Affairs with FDA, EMA, Health Canada, MHLW and PMDA Regulations of Pharmaceutical products and Medical Devices
Korea Nazarene University Cheonan, South Korea, Expected in 02/2016 Master in Education : Teaching - GPA :
  • 4.0 / 4.5 GPA
  • Thesis: Educational Assessment Techniques
  • Dean's List Honoree Summer and Fall Semester, 2015.
  • Major in Education
  • Completed professional development in Teaching and Assessment Techniques
University Of Buea Buea, Cameroon, Expected in 11/2011 Bachelor of Science : Microbiology And Parasitology - GPA :
  • 3.0 / 4.0 GPA
  • Honor Roll ( Second Class Upper Division)
  • Thesis: Microbial Contamination of drinking water in Buea
  • Minor in Medical Laboratory Technology
Experience
Peoria Unified School District - High School Biology Teacher
Peoria, AZ, 08/2019 - Current
  • Evaluated submitted assignments for clarity and skills, assigned grades and discussed results with struggling students to enhance uClairerstanding of course objectives.
  • Explored different avenues of learning with students to help each prepare for later educational environments.
  • Assessed student progress with course material through routine quizzes, final examinations and standardized assessments.
  • Managed consistent, learning-focused classroom environments by establishing and communicating clear objectives for all students.
  • Adapted teaching methods and instructional strategies to promote learning in students of differing skill levels.
  • Explained proper lab techniques to students.
Sunrise Senior Living - Certified Nursing Medication Technician
City, STATE, 11/2017 - 08/2019

Examined and addressed lacerations, contusions and physical symptoms to assess and prioritize need for further attention.

  • Documented information in patient charts and communicated status updates to interdisciplinary care team.
  • Collected biological specimens and packages for laboratory transport to complete diagnostic tests.
  • Obtained, recorded and reported patient vital signs as needed for medication administration.
  • Safely and accurately prepared all medications and sterilized products by using proper techniques, calculations and standards of precautions.
  • Verified patient identities using prescribed protective measures to meet facility and regulatory requirements.
  • Recorded observations and baseline measurements to maintain accurate medical records.
  • Collected, documented and reviewed patient medical histories and relayed important factors to supervising clinicians.
  • Accurate and Timely administration of patients' Medication
  • Shift supervising and reporting to Coordinator, Nurse director, and Executive director of Assisted living
Mount Zion Clinic - Medical Microbiologist and Laboratory Technician
City, STATE, 11/2011 - 03/2013
  • Collected, labeled and stored lab samples according to laboratory specifications.
  • Enforced infection control and sharps disposal procedures to protect patients, co-workers and self.
  • Adhered to all laboratory requirements and enforced compliance with regulations.
  • Audited specimen integrity and identification.
  • Isolated, identified and prepared specimens for examination.
  • Analyzed experimental data and interpreted results to draft reports of findings.
  • Recorded, reported and posted specimen results in company software.
  • Cleaned and sterilized lab area, tools and equipment.
  • Maintained detailed logs of all experiments and relevant data and updated databases with new information.
  • Followed laboratory guidelines for handling biological specimens.

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Resume Overview

School Attended

  • University Of Maryland Global Campus
  • Korea Nazarene University
  • University Of Buea

Job Titles Held:

  • High School Biology Teacher
  • Certified Nursing Medication Technician
  • Medical Microbiologist and Laboratory Technician

Degrees

  • Master of Science
  • Master in Education
  • Bachelor of Science

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