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Quality Specialist Resume

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Skills:

  • Proficiencies with Microsoft Office and associated applications
  • Proficient in coordinating Audits outside vendors and Internal as well
  • Expertise in training personnel on QA regulations and GMP
  • Skilled in dealing with all levels of staff, production through management
  • Ability to work independently, solve problems, and make recommendations
  • Strong leadership, interpersonal and employee development skills
  • Bilingual: English/Spanish and fluent simultaneous translator

Education: Bachelor in Chemistry and Biology.

    • Microsoft Specialist II: Excel, Word, Power Point, Outlook, and Access
    • Internal Auditor Training for ISO 9001
    • The Essentials of Communicating With Diplomacy and Professionalism
    • Lean Logistic

Experience:

Confidential in Wayne, N.J. Nov 2010 – Present
Quality Specialist
Responsibilities:

  • Developing and Implementing electronic QMS document control system
  • Leading and creating the Manufacturing Orders process
  • Support new product development and obtaining Customer Approval
  • Analyze data to develop recommendations for manufacturing improvements

Confidential in Elmwood Park, NJ Jun 2010 – Oct 2010
Quality Regulatory Compliance Assistant
Responsibilities:

  • Created Work Instructions according ISO 13485 requirements
  • Established an outstanding customer service with 78 Subcontractors to obtain the regulated documentation for Approved Supplier List (ASL)

Confidential in Fairfield, NJ May 2008 – Jun 2010
Document Control Specialist
Responsibilities:

  • Ensure all Quality Management System documents are properly controlled, maintained and protected.
  • Assist plant personnel in developing preventive/corrective actions by collecting relevant quality data, analyzing issues
  • Assist on the internal audit team, and participate in external audits
  • Maintain an in-depth working knowledge of ISO and FDA requirements.
  • Responsible for reconciliation and training of manufacturing personnel on SOP’s and WI’s procedures and practices across functional disciplines.
  • Translated all Manufacturing procedures: SOP’s and WI’s
  • Verify ECN (Engineering Change Notification) and Print Approval and maintain Engineering Library.
  • Lead cross-functional teams to complete special projects and support continuous improvement of work instructions and operating procedures.

Confidential in Franklin Lakes, NJ Jan 2008 – May 2008 
Vendor Master (Temp)
Responsibilities:

  • Moved from hard filing system to electronic
  • Created, changed, and reviewed Vendor profiles in SAP program
  • Audited and verified vendors Bank information
  • Audited W-9 forms.

Confidential in Riverdale, NJ Nov 2005 – Nov 2008
Quality Supervisor:
Responsibilities:

  • Worked on behalf of QA Manager.
  • Monitored the QA Document Control system.
  • Coordinated ISO Audits: Internal and External.
  • Monitored the CRS system (Customer Response System)
  • Performed contract reviews of Manufacturer Orders required documentation
  • Monitored Preventive/Corrective Action System.
  • Participated on Lean events to improve production efficiency and eliminate waste.
  • Performed assembly, 1st piece inspection, and Final inspection on the shop floor.

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