Orlando Carrasco

*** ********* ***** ***. *

McPherson, KS 67460

915-***-****

acfw9g@r.postjobfree.com

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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