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)
