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Packaging Scientist Resume

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Morganville New, JerseY

Job Objective:
To obtain a positionas a Documentation Control Specialist utilizing my education and past experience for advancement and to help company meet and surpass both short and long-term goals.

Summary of Qualifications:

  • Experienced working as a Quality Control inspector
  • Strong knowledge of the Quality Standards and procedures including documentation management
  • Ability to prioritize the work accordingly to meet all the deadlines
  • Experience with Change Control and electronic change control tracking (trackwise)
  • Skilled at working under pressure and performing multiple tasks at once
  • Proficient in Trackwise applications, MS Word, MS Excel, and Power Point
  • Highly motivated and committed to delivering top quality testing and analysis
  • Excellent ability to report findings and discrepancies

Experience:

Senior Packaging Component Specialist (Documentation)
Confidential, New Jersey 2001 - 2010

  • Responsible for preparation and control of primary and secondary package component specifications maintained within an electronic document management system
  • Monitored multi-stepped document approval process
  • Created AutoCad drawings for primary and secondary package components
  • Prepared comprehensive change control documents maintained within an electronic change management system (Trackwise).
  • Monitored and maintained packaging related New Drug Application submission documentation
  • Coordinated with R & D to develop packaging related documentation for new product lines
  • Prepared departmental Standard Operating Procedures
  • Improved and revised procedural documentation defined by regulatory standards
  • Strongly Adhered to cGMP requirements
  • Trained personnel on new/revised document usage
  • Maintained electronic and hard copy filing systems
  • Administered companywide Part Number System

Packaging Scientist
Confidential, New Jersey 1981 - 2001

  • Obtained samples of pharmaceutical primary packaging components from clinical supply warehouse inventory for quality control inspection and performed inventory reconciliation
  • Conducted incoming quality control inspection of pharmaceutical primary packaging components intended for use in clinical manufacturing (visual, dimensional, functional and identity tests)
  • Performed testing and conducted complex experiments to evaluate existing and new primary packaging components and medical devices
  • Prepared comprehensive reports to document results from laboratory experiments
  • Operated measurement devices such as optical coordinate measurement instruments, calipers/micrometers, and mechanical material testers
  • Selected by manager to train new employees due to demonstrated knowledge
  • Participated in packaging demonstration runs, both internally and at contract packaging facilities
  • Strictly adhered to cGMP and cGLP requirements

Skills:
Proficient in Trackwise applications, MS Word, MS Excel, and Power Point

Education:
Bachelor of Science Degree (CICS)

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