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Quality Assurance Auditor Resume

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OBJECTIVE: Would like an opportunity to apply proven skills in Quality Assurance to increase thequality and
efficiency of job completion, keeping within deadlines and budget leading to satisfaction for both
employer and customers.

COMPUTER SKILLS:

SAP | Microsoft Word | Excel
Access | Power point | Score & Gx-Pharma
SQL *LIMS | Microsoft Outlook | Trackwise

EXPERIENCE:

Confidential, Forest, VA
Quality Assurance Auditor. Jun 2006-Aug 2009.

  • Successfully introduced changes to eliminate re-work and downtime resulted in profitability.
  • Reviewed Documents, Records, Lab Data and Packaging Orders as per FDA Quality standards.
  • Followed and implemented Acceptable Quality Level with MIL-STD-105 E, ISO 1999.
  • Initiated Non-Conformances upon violation of SOP, assigned task to pertaining department.
  • Created R & D and Technical inspection lots in SAP, reviewed and unlocked.
  • Monitored SAP to generate Process Orders for Mfg. as batches released by planning.
  • Solved problems arisen during production related to quality and cGMPs.
  • Visited production area to make sure all procedures, protocols and SOPs are followed.
  • Filed batch records, documents, references and retrieve them whenever FDA requires.
  • Well conversant with computer, data entry, company's ERP systems 21 CFR-11 and Network.

Aug 03-June 06 Packaging Technician. Confidential

  • Checked components, raw materials for accuracy in accordance with packaging order.
  • Reconciled printed literatures, materials and components after completion of production.
  • Trained team members in running lines, change over, set-up and documentation.
  • Understood and strictly followed SOPs, cGMPs, Protocols and Quality procedures.
  • Constantly volunteered to work over time in R & D for inspecting components, finished goods, and conducting inventory of raw materials.
  • Well conversant with metric system, AQL, SAP and MS office suite.

Dec 97-Aug 03 Confidential, Lynchburg, VA
Robotic Operator/Team Leader- Printed Circuit Boards.

  • Line change over, machines set-up, testing, assembling, auditing in a very fast-paced environment.
  • Responsible for inspecting each part for accuracy and quality as per specifications.
  • Certification in advance soldering. Awarded for perfect attendance and high accuracy.

Aug 97-Dec 97 Confidential, San Jose, CA
Inventory Associate

  • Inventory, sampling components received from vendors.
  • Issued accurate and exact parts for production as per pick list.
  • Entered Data, picked and shipped components to customers as per order.

Jan 75-Jun 97 Confidential, Ahmedabad, India.
Statistician. (April 85 to June 97)

  • In charge of Medical Record dept. implementing procedures, solving problems, furnishing information of communicable diseases to government on daily basis.
  • Compiled statistics from all relevant dept. Preparing and publishing Annual Reports.

Medical Store Accountant (Jan. 75 to April 85)

  • Reviewed, audited, tallied vendors invoices with the shipment voucher and authorized payment.
  • Performed sampling, quality inspection for each item received from vendors.
  • Issued items to all dept. as per demand, maintained inventory in system.
  • Purchased laboratory instruments from market in case of emergency.
  • Responsible and entrusted for large sum of cash money.

PERSONAL QUALIFICATIONS:

  • 0% absent & tardiness in past 12 years, as well as at prior employment.
  • Exceptional problem solver, driven to succeed with strong interpersonal and communication skill.
  • Never called from home requesting vacation or personal time.
  • Constantly demonstrated amicable rapport with team members.
  • Utilized exceptional business judgment and time management skill to balance efforts
  • in the field, multi-tasking to ensure production goals and quality are exceeded.
  • Awarded for excellent work, exceeding expectation and 100% attendance.
  • Well conversant with FDA rules and regulations, CFR and SPC, strictly implementing them.

EDUCATION

Bachelor of Arts

  • Double major in Economics and English Literature.
  • Worked as a private tutor throughout college to pay tuition fees & books expanses.
  • Diploma Higher Secondary School.
  • Served 2 years as a school President.
  • Won the title of Champion in District Chess Tournament.
  • One semester in Microsoft Office Suite from Community College, Lynchburg. VA.
  • License for Forklift Driving, Barr Laboratories.
  • Certificate in Internet savvy and Electronic Marketing, Community College, VA.
  • Certificate of Completion DEA compliance.
  • Advance Leadership Training, Haggai Institute, Singapore.

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