Quality Assurance Control
Resume:
Shanese Page, M.B.A
West Orange, NJ
***********@*****.***
Summary
Highly creative individual and self-starter with 9 year’s experience in the pharmaceutical industry. Very motivated and committed to professional standards and meeting deadlines/goals. Excellent communication skills and a remarkable talent for creating productive working relationships between all levels within an organization. Excellent leadership skills with proven ability to motivate and work effectively with others.
Professional Experience
Genzyme, A Sanofi Company Ridgefield, NJ 2011-present
Quality Specialist
• Review manufacturing formulation batch production records to ensure compliance with internal specifications and cGMP regulations.
• Compile history records for medical lots in preparation for product release.
• Draft and review specifications and SOP’s.
• Update and revise SOP’s into new approved format.
• Monitor and trend batch record errors.
• Provide quarterly/yearly Metrics to Quality Assurance management with quality indicator data.
• Review analytical and microbiology specifications and testing using the LIMS system
• Perform batch record closure and product disposition.
• Assist planning and manufacturing departments with process improvements and new innovative projects
• Maintain shipping schedule based on customer demands.
• Train and mentor new employees
• Process documentation from draft through approvals
Reckitt Benckiser Montvale, NJ 2009- 2010
Associate Scientist (R&D Scientific Service Department)
• Daily activities required ability to multitask, exhibit strong time management, organizational and analytical skills while delivering a high level of professionalism and accuracy
• Assisted with providing manufacturing documentation for regulatory department
• Ability to compute, analyze and interpret results
• Investigate and report consumer complaints into word based tracking system
• Write technical reports and prepare standards and specifications for processes, facilities, products, or tests
• Strong understanding of documentation and laboratory notebooks
SULTAN HEALTHCARE, Englewood, NJ 2007 - 2008
Quality Assurance /Quality Control Chemist
• Compiled laboratory test data and perform appropriate analyses using Empower software.
• Evaluated analytical methods and procedures to determine how they might be improved
• Investigated and reported questionable test results
• Participated in out-of-specification and failure investigations and recommended corrective actions.
• Performed final review of batch records before closing out records.
• Performed line pre and post line clearance on manufacturing line
BRISTOL-MYERS SQUIBB New Brunswick, NJ 2004-2007
Pharmaceutical Technician (Stability/Bio-pharmaceutics Dept.)
• Participated in the review and development of departmental SOPs and stability protocols
• Maintained laboratory documentation and equipment under strict compliance with safety, GLP, federal state and local regulations
• Managed stability chambers
• Prepared and labeled samples of standards and reagents
• Calibrated instruments in accordance with SOPs
• Performed data entry, record keeping and inventory tracking
Education
Masters in Business Administration
Centenary College 2008
Bachelors of Science, Chemistry
Montclair State University 2004
COMPUTER SKILLS
Microsoft Word, Excel, PowerPoint, Track Wise Systems, MS Outlook, knowledge of PDLIMS
AWARDS
Bristol Myers Squibb Awards, PRI Star Award, 2005
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