Quality Associate Resumes in Canada-Ontario: Maham

Quality Associate Resume

Contact Candidate

Name:

Maham

Location:

Canada-Ontario

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Quality Associate

Personal Website:

Objective:

To obtain a challenging and rewarding position in Regulatory Affairs that would allow me to enhance and utilize my strong regulatory, technical, and communication skills in the biotechnology/pharmaceutical industry

Resume Text:

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hns Hopkins University, Baltimore, Maryland

Bachelor of Applied Science, Chemical Engineering Sept 2001-June 2005 University of Toronto, Toronto, ON
Graduation: June 2005

RELATED COURSES
Clinical Development of Drugs & Biologics, cGMP Compliance, Regulatory Processes, Product Development, Food & Drug Law, Marketing in a Regulated Environment, Managing Biotech Professionals
Undergraduate Thesis: “Microemulsions as drug delivery vehicles” Aug 2004–April 2005
• Designed experimental procedures for studies involving linker microemulsions to enhance the transdermal delivery of local anesthetic, lidocaine, with increased bioavailability and minimum toxicity effects

SPECIAL SKILLS
Computer: Microsoft Office (Excel, Word, Visio, Access, PowerPoint, Outlook), Maple, AspenPlus, SolutionsPlus, XLstat, C++, CES Selector, OnAir Database, AutoCAD, SAP
Languages: Fluent in English, Urdu, Hindi, Punjabi; working knowledge of Spanish

WORK EXPERIENCE
Manufacturing/Quality Associate Oct 2005 – Sept 2006
Nanogen Inc. – Cardiac Diagnostic test kit (IVD) manufacturing division Toronto, ON
• Executed In-Process, release, and stability testing activities pertaining to manufactured products.
• Optimized in-process components for use in manufactured products.
• Created and implemented Standard Operating Procedures and Validation documentation to meet established quality standards.
• Validated process equipment (IQ, OQ, and PQ), and prepared validation protocols and manuals
• Conducted data analysis and interpretation of results.
• Engaged in process development, for increased quality and reduced costs, to improve products that are already in manufacturing stages.
• Managed the production assembly team by providing appropriate supervision and direction in the manufacture and assembly of cardiac diagnostic kits.

Design Engineer, Chemical Plant Design Sept-Dec 2004
University of Toronto - Department of Chemical Engineering
Effectively collaborated in a six-person team for the design of a 200,000 annual ton polyethylene (LDPE) manufacturing plant
• Developed an in-depth process outline and the plant layout (PFDs & P&IDs)
• Designed and sized process equipment, and researched markets for economic comparisons
• Conducted a detailed environmental, health and safety assessment
• Prepared detailed written reports and delivered presentations to clients – faculty and industry representatives
TECHNICAL COMMUNICATION
Product Development Project (Grade: A) Jan – April 2007
• Worked in a team of five to design the planning of a cancer therapeutic in the form of a monoclonal antibody to present in front of a team of (hypothetical) venture capitalists
• Prepared an extensive presentation that covered the research, bioprocess development, CMC, pre-clinical, clinical, legal, and regulatory aspects of the drug development process

Law Project (Grade: A) Jan – April 2007
• Performed extensive literature research that studied the effects of prescription drug promotion in the U.S. under the Food, Drug, and Cosmetic (FD&C) Act
• Prepared a comprehensive paper that analyzed the current regulatory framework and suggested improvements

cGMP Compliance Project (Grade: A+) Sept – Dec 2006
• Worked in a team of five to prepare a comprehensive compliance program for a biotech manufacturing facility in the area of Personnel Training, including SOPs and company policy
• Prepared a comprehensive report and presented to class

EXTRACURRICULAR ACTIVITIES
Health and Safety Committee Member, Nanogen Point-of-Care Diagnostics Oct 2005 – Sept 2006
• Actively involved in working in a team environment to plan and implement the health and safety
standards in the corporate and laboratory facilities

V.P. Finance, Club for Undergraduate Biomedical Engineering (CUBE) April 2003-April 2005
• Actively involved in dealing with industrial sectors to co-ordinate and organize events to foster ties between university and industry
• Worked with other executives to triple the number of events and activities offered to students compared to previous years
• Monitored club expenses and income, and prepared the annual budget

Industrial Conferences
• Served as a Moderator in the RAPS 2006 Annual Convention in Baltimore, MD
• Volunteered as a room monitor in the Biotechnology Industry Organization Annual Convention (BIO2003) in Washington DC, (BIO2004) in San Francisco, & (BIO2005) in Philadelphia.
• Assisted the RAPS and BIO teams in moderating sessions and ensuring that any concerns of the attendees were addressed appropriately

PROFESSIONAL AFFILIATIONS
• Regulatory Affairs Professional Society (RAPS)
• International Society for Pharmaceutical Engineering (ISPE)
• Parenteral Drug Association (PDA)
• Professional Engineers Ontario
• Genetic Engineering News

HONORS
Canada Millennium Scholarship
Leon J. Rubin Scholarship Award (Chemical Engineering, U of T)
Aiming for the Top Tuition Scholarship
Dean’s Circle (2001, 2005)
Ontario Scholar

REFERENCES AVAILABLE UPON REQUEST

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