Manufacturing Associate Biopharmaceutical Resume Example

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

Energetic Biopharmacuetical professional dedicated to providing top-quality to support the overall GMP manufacturing and quality processes, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologic's from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. My previous experience with both patient-centered care, research and biopharmaceutical manufacturing allows me to provide unique and diverse needs to your organization.

  • 21 CFR Parts 210 & 211
  • FDA compliance
  • CGMP compliance
  • SOP comprehension
  • Quantitative and qualitative analysis
  • Process Development
  • Medical terminology knowledge
  • Infection control procedures
  • Quality assurance controls
  • EHR Management
  • Good clinical practice
  • Analyzing and synthesizing data
  • Laboratory operations
  • Empirical research
  • Clinical research
  • Laboratory testing
  • Risk management
  • Documentation procedures expert
  • Document Control
  • HIPAA compliance
  • Customer Service
  • Microsoft Office
  • Lab experiments and research
  • Research methods
  • Project management
  • Training & Development
  • Strategic planning
  • Patient Care and Education
08/2021 to Current QA Analyst Us Government Other Agencies And Independent Organizations | Greenwood Village, CO,
  • Interface and communicate with the Client, Analytical Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues
  • Perform quality review of Analytical Development documentation including raw data, test methods, protocols and executed method qualification reports
  • Provide quality oversight of process and analytical method development in an R&D setting for client projects
  • Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
  • Support the CAPA Tracking System and track the timely completion and extension of commitments
  • Conduct review of demonstration batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate
  • Generate, revise and review Pre-Clinical Services Standard Operating Procedures (SOPs) and other documentation as needed
  • Responsible for material release
02/2021 to 08/2021 Manufacturing Associate - Biopharmaceutical Sunset Communities | Grandville, MI,
  • Performed a variety of tasks including but not limited to process execution and monitoring to assure vaccine product quality and manufacturing throughput.
  • Accurately completed paperwork and electronic transactions for all documentation requirements including but not limited to SAP transactions, batch record steps and paper and electronic logbooks.
  • Performed the final checks/ verifications for operations as indicated in the batch records and SOPs Order and receive material and perform the required identification and use (i.e. RFI system and basic SAP).
  • Worked with the team to ensure all aspects of the business remain compliant and in an audit ready state.
  • Maintained proper inventory levels of clean tools including ancillary equipment, pallets and containers.
  • Adhered to all applicable regulations, policies and procedures for health, safety and environmental compliance.
  • Prepared and assembled materials and set up and operated production equipment in accordance with current manufacturing practices and standard operating procedures.
  • Executed the manufacturing and packaging operation with an adequate supply of components using mechanical apparatus, automated equipment and manual processes.
08/2018 to Current Research Assistant Atlantic General Hospital | Berlin, MD,
  • Created and implemented new research methods to explore mechanisms of biological processes.
  • Executed qualitative and quantitative analysis on wide range of data.
  • Managed critical paperwork such as informed consent forms and personal waivers.
  • Designed and implemented program macros to carry out statistical analyses.
  • Studied physical principles of cells, organisms and electrical or mechanical energy.
  • Screened participants enrolled in research study, administering relevant tests and surveys.
  • Designed research and experimental studies and executed research techniques, tests and assays.
  • Compiled and organized research data to produce reports and graphs.
  • Supported project leads in preparing regulatory documentation and presentations highlighting findings.
08/2018 to 01/2021 Certified Nursing Assistant Franklin Square Medical Center | City, STATE,
  • Documented activities and recorded information in EMR system.
  • Collaborated with interdisciplinary healthcare teams to provide high-quality patient care.
  • Supported diagnostic and treatment procedures, including setting up and operating specialized medical equipment.
  • Maintained accurate, timely flow of information by completing thorough patient records and updating healthcare team on patient status.
  • Responded to patient alarms and needs-assessment requests to identify course of treatment.
  • Collected specimens, monitored vitals and maximized patient comfort to maintain optimal environment.
  • Administered personal nursing assistance in pre- and post-operative situations.
  • Conducted routine checks on standard patient vitals, including blood pressure, blood sugar and heart rate.
  • Fostered relationships with patients, caregivers and healthcare teams to achieve individual care plan targets.
  • Documented patient intake and dietary requirements, also assisting with feeding and monitoring.
  • Exhibited compassionate care and communication regarding issues surrounding death and dying.
Education and Training
Expected in Bachelor of Science | Biology Morgan State University, Baltimore, MD GPA:
  • Deans List Honoree
  • Certified Nursing Assistant
  • Geriatric Nursing Assistant
  • First AID/CPR
Memberships and Organizations

Student Research Center (Morgan State University)

Iota Phi Theta Fraternity Inc. (National Pan-Hellenic Council)

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Resume Overview

School Attended
  • Morgan State University
Job Titles Held:
  • QA Analyst
  • Manufacturing Associate - Biopharmaceutical
  • Research Assistant
  • Certified Nursing Assistant
  • Bachelor of Science

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