Quality Assurance Engineer
Resume:
Orlando Carrasco
McPherson, KS 67460
***.****@*****.***
Experience
Experience in Quality Assurance Pharma and Pharmaceutical Manufacturing
environment
Experience in Quality Assurance Drug and Medical Device Manufacturing
Environment.
Experience in FDA, GMP and ISO (9001:2008 and 13485) requirements.
Experience with established rules, procedures, and methods
Knowledge of quality engineering policies, principles and best practices
and statistical sample size calculations to work for quality determination
on projects of more advanced scope and complexity
Knowledge of applying and evaluating techniques for the identification,
consideration and resolution of issues concerning the efficiency and
effectiveness of quality assurance operations.
Knowledge of business and industry quality assurance management practices,
capabilities, capacities and trends and the analysis.
Knowledge of sources, responsibilities and means for providing assistance
and advice to resolve complex quality assurance problems
Knowledge of supplier capabilities, materials and production methods,
emerging technological developments and improvements, current economic and
market trends, and optimum supplier acquisition strategies.
Mentor to less experienced team members to provide strategic guidance and
provide guidance on regulatory guidelines
Apply understanding of regulatory requirements (cGMP, FDA, ISO etc.) to
support work
Write test protocol, tests, collects data, and reports to validate against
plan to ensure products are used as intended.
Perform investigations to identify the root cause of customer complaints
resulting from manufacturing areas.
Competed and Certified on TPPS Level II and Level III certification and
Advance Security Officer Courses.
Completed an Internal Auditor Course presented by SAI Global.
Perform Supplier Audits to verify quality systems are in place with Raw
Material Suppliers.
Personal Experience
Over 14 years of leadership and management experience with a reputation for
meeting the challenges of organizational goals and objectives. A focused
individual recognized for making decisions and maintaining corporate
quality policy.
Produced higher performance standards and enhancing productivity during a
period of shrinking budgets by introducing a manufacturing process
"Integrate Quality Inspection Process" (IQIP). This process introduced
the manufacturing operators into inspecting their own products. This
allowed in reducing of QA technicians as a cost reduction.
Reduction of Non-Conformance (NCR) in manufacturing by 52% was
accomplished by verifying machines set-up and retraining of manufacturing
associates. A reduction of reworked operations was also noted.
Controlling Supplier Management - Introduce a Supplier Management system
that monitors suppler performance and allowed for an increased in
communication with suppliers concerning supplier nonconformance's and
product improvements.
Develop and implement highly successful strategic reduced sampling plans
performed by the QA technicians. Established reduced sampling plans for
incoming inspection and manufacturing areas without compromising the
quality of the product.
Responsible for the CAPA system, in the manufacturing area. CAPA's
generated in manufacturing became projects which included processes, of
machinery and or material. Responsible for CAPA's from customer complaints
which involved the manufacturing process.
Hospira Inc. 2012 -
Present
Supplier Quality Engineer
Responsibilities include performing on site Supplier Audits on
suppliers that provide raw materials to the company. Suppliers include API,
Excipient and Component manufactures. Report and responsible for monitoring
Incoming Quality product monthly metrics, Customer Change Notification
reporting to Corporate. Report on Approved Products Quality Reports
(APQR). Create Change Request to SOP's, Specifications and Work
Instructions. Also responsible for Supplier responses to Quality Alert
Notification (QAN) and CAPA's associated with Suppliers.
Alaska Structures Inc. 2011 - 2012
Quality Engineer
Successful implemented of ISO 9001:2008 on two manufacturing
facilities. Responsibility included generating SOP's, Flow Charts,
procedures and training of associates. Alaska Structures manufactures
fabric tent building structures used by the military and now going
commercial. The structures are made in a variety of sizes and are used
throughout the world as permanent or temporary structures.
CareFusion Inc
Quality Assurance Manager
2007-2011
Responsible for all Quality activities that support manufacturing
operations for the production of finished product to include: in-coming raw
materials, production process and assembly inspection, packaging, finished
product release, shipping and investigation of customer complaints.
Responsibilities include maintaining the quality operations within expense
budget.
Responsible for all applicable Quality Management System elements
that for the production and manufacturing areas and assign projects for the
improvement of operational processes, Ensure that all documentation is
maintained as required per procedures. Ensure that regulations/procedures
are being followed. Oversee all validations of equipment and products and
ensure validations of processes & machinery are performed. Ensure that we
are in compliance with FDA, MHRA, GMP/ISO and corporate procedures are
being followed throughout the facility. Ensure that all employees in
Operations and Quality are trained to cGMP annually and ensure that all
areas of operations are in compliance with applicable procedures and
training. Direct the Supplier Management program for supplier compliance
to corporate policy.
Directly managed 33 employees, (2) Quality Engineers, (4) Quality
Supervisors, (5) Quality Coordinators and (22) Quality Technicians for the
manufacturing operation, incoming and finished goods for three shifts.
Directed activities for all supporting staff assigned to Quality
Operations. Ensure that all Quality staff members have the necessary
training and tools to successfully accomplish their jobs. Design,
implemented coaching and training programs all QA operations staff members.
Maintain constant communication with QA staff with updated information by
having daily meeting for all three shifts thus resulted in a more informed
unit. Provide monthly presentation of company financial status and updated
information of new and up coming projects to QA staff.
Interface with customer audits, certification body auditors and FDA
inspections. Perform on-site Supplier audits as Lead Auditor. Actively
interface with Vendors and upper management regarding quality issues of
products and team work projects such as customer complaints, Non-
conformances and CAPA's and determine root cause analysis and arrive at a
corrective action. Work with improving manufacturing processes through
Lean manufacturing by having Kaizen events and 5S events. Develop and
implement highly successful strategic reduced sampling plans in the
production floor performed by the QA technicians. Coordinate with the
Engineering group in validation activity of machinery, processes, and new
products. This includes MVP, PFMEA's, FMEA's and Risk Assessments.
Enturia Inc.
2003-2007
Quality Engineer
Responsible for the direct management of auditing operations, internal,
external and third party audits activities. Audited departments company
procedures FDA Pharmaceutical Regulations, CMDCAS, MHRA and ISO standards.
Perform on site Supplier audits as Lead Auditor to ensure that the Raw
Material operations, manufacturing, and all warehousing operations are in
compliance. Actively interface with Vendors regarding quality issues of
products.
Coordinate with the facility Engineering group in validation activity of
machinery, processes, and new products. This includes MVP, PFMEA's, FMEA's
and Risk Assessments. Analyze data for acceptance of first articles from
the vendor and perform our own internal test and analysis. Verify that all
calibration of measuring equipment is performed and calibration
certificates are filed.
Cardinal Healthcare: / Allegiance
El Paso TX
2000-2003
Quality Assurance Supervisor
Responsible for maintaining medical device regulatory compliance of
products manufactured in the El Paso TX facility. These consist of
operations in the manufacturing area, return goods and shipping operations.
Direct reports of (3) Quality Assurance Coordinators, (10) Quality
Assurance Inspectors for three shifts.
Responsible for maintaining all updated Calibration and CAPA documentation.
Develop and present training material to all Finished Goods Warehouse
personnel of changes to procedure and to new personnel.
Allegiance Healthcare: / Baxter
1998-2000
El Paso TX
Quality Assurance Specialist; responsibility consisted of performing
validations new manufacturing machinery and analyzing data being collected
for continuous improvements on current products. Develop training material
presentation for Return Goods and Warehouse personnel of changes to
procedure and to new personnel.
Baxter Healthcare: / American Hospital Supply
1979-1998
Raw Materials QA Lead; responsible for 4 Lab technicians and 5 raw material
inspectors. Generate a working scheduled for incoming products for
sampling, testing and completing all documentation necessary for the Raw
Material laboratory for testing. Assign projects as required by QA
management.
Education:
University of Phoenix
MBA - Masters in Business Administration 1997-1999
University of Phoenix
BAB -Bachelors of Art in Business 1995-1997
El Paso Community College working on degree in BA 1993-
1994
El Paso Community College working on degree in Med Lab Technology 1973-
1977
Bel-Air High School, El Paso, TX
1970-1973
El Paso Community College: 2011 June
TPSB Level II Training Certificate completion June
14, 2011
Basic Security Officer Level Three Firearm Certificate completion
June 14, 2011
Advance Security Officer Course; Self-defense, Defensive Tactics,
June 17, 2011
Certificate completed on Take-downs, Hand-Cuffing, OC Spray, Baton
Training.
ISO 9001- Internal Auditor Course, presented by SAL Global
March 7-8, 2012
Training/Seminars:
Introduction to Professional Writing, Basics of Supply Chain Management
(APICS CPIM), Training on Root Cause Investigation for CAPA (FDA), HR
Choice for Professional Training and Development, Lean Manufacturing:
Setting Your Priorities, Problem Solving in your area, How to be a
successful Supervisor, Time Manger and Managing your Supervisor, Valuing
Diversity, and Managing Multiple Priorities.
Computer Skills: Ability to operate following programs: CIMA, Access,
Project Management, Microsoft Windows, Words, Excel, Power Point,
Minitab, outlook lotus notes.
Languages: Able to read, write and speak English and Spanish fluently.
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