FRANCISCA AVILA POPOCA1321 Columbine Blvd, Colorado Springs, CO 80907 | M: 719-229-5718 | favilap@its.jnj.com

ProfileDedicated professional with 16+ years’ experience working in a regulated company. I specialize in manufacturing process procedures, GMP, Quality System Regulations; ISO 9000 and FDA requirements 820 CFR 21 with excellent communication skills.

Skills C#, ASP.NET, Word, Excel, Show Case, AUTO CAD, MINITAB, INTRALINK, WINDCHILL, Adaptive, CDR,

EtQ, Think-cell

Familiar with: Microsoft Project and Microsoft SQL Server

Solid knowledge of Microsoft Office Products

Platforms: Microsoft Windows XP, Window 7, Windows 10.

Toastmaster: communication and leadership skills

Coaching for Supervisor and manager class certificate.

Fluent in SpanishProfessional Experience

Packaging Engineer Technician 10/2010 to Current DepuySynthes companies of J&J

Author of IQ, OQ, and PQ Protocols. Perform equipment Validation. Author of Work Instruction and Process procedures in Adaptive. Author of production forms for packaging requirements. Knowledgeable with Quality Regulations; ISO 9000 and FDA requirements 820 CFR 21. Author of Process procedures that conform to Quality System Regulations. Revise Process Sheets to reflect current operations according to Work Instructions in US and EU or new

requirements in compliance to Quality System Regulations. Train an audience of operators, supervisors, and managers on new process operations and requirements. Acquisition purchases for production equipment, materials, and production accessories. Act as a liaison to vendors in regards to tools, fixtures, and equipment. Experience resolving CAPAs utilizing cause and effect diagrams. Author of work instructions. Author of Process Tests. Author of quality document changes for current procedures and new procedures. Create, change, and maintain product routers. Responsible for investigating and disposition of non-conformances for product and procedures. Responsible for preparing audit readiness procedures and process flows. Key player in mislabel Kaizen event. Knowledgeable with PFMEA process. Analyze Statistic data results utilizing Minitab program. Author of procedures for Cleaning Rooms for ISO class 5 and Class 7. Member of JJOS deployment team.

Synthes, USA

Quality Inspector 05/2003-10/2010 Inspect medical devises per product drawings (blue prints). Inspect product with CMM measuring machine, calipers, micrometers, and tensile tester. Review Document Mater Records for accuracy and completion. Author of process procedure for peel tester machine. Design and implemented Quality Assurance database for order completion tracking. Write Manufacturing changes to implement process procedures. Prepare raw material samples for lab testing.

Material Handler 03/2000- 05/2003 Distribute product to inventory locations. Receive product into stock locations utilizing inventory database system.

Programmer Analyst 01/2010 to 01/2011District Attorney's Office

Primary responsibilities include design and development of server code. Developed applications using C# in conjunction with ASP.NET. Designed and developed relational databases using SQL server. Convert Microsoft Access databases into SQL server databases to be accessed through the server using

ASP.NET applications.

Education

B.S: Computer Science and Information Systems 2010Regis University Denver, Colorado, USA