Janina Navarro

acbkf7@r.postjobfree.com

Overland Park, KS 66207 Phone: 913-***-****

MANUFACTURING AND QUALITY MANAGEMENT

Accomplished Manufacturing and Quality professional with 13 years overall experience inclusive of 8

years supervisory/management experience. Viewed as a qualified leader in a fast paced

biopharmaceutical manufacturing organization, results and innovation focused, and a team player with a

proven record of strong performance in all quality systems aspects.

PROFESSIONAL COMPETENCIES

- Lean Principles - CAPA/Nonconformance Investigations - Trackwise

- cGMP practices - ISO and Regulatory Requirements - TeamCenter

- cGDP practices - Quality Systems - JD Edwards

- Planning and Budgeting - Supplier Audits, Regulatory Audits - LIMS

PROFESSIONAL EXPERIENCE

Baxter Healthcare Corporation – Los Angeles, CA May 2010 – July 2013

(Baxter had 2012 sales of $14.2 billion and has approximately 50,800 employees)

Los Angeles Facility: ~1300 employees

Quality Manager – Quality Operations, Supplier Quality, Receiving Inspection Mar 2012 – July 2013

Quality Manager – Supplier Quality, Receiving Inspection July 2011 – Mar 2012

Quality Manager – Receiving Inspection May 2010 – July 2011

Managed 3 Quality departments and provided Quality Systems support to the Van Nuys Warehouse (raw material

logistics to/from Los Angeles Manufacturing Facility; domestic and international distribution center for

manufactured products)

• 5 direct SEE/SNE reports, 10 indirect SNE reports (plus Quality support for the Van Nuys

Warehouse functions totaling 90 personnel)

Accomplishments:

o Completed Baxter’s Supplier Auditor Certification and active in leading Supplier Audits (for raw

materials such as components, medical devices, and chemicals)

o Completed the Baxter Management Essentials Certification Courses

o Built added organizational roles and capabilities to the Los Angeles Facility extension location (Van Nuys

Warehouse) by integrating three quality departments into one cohesive department structure supporting both

Los Angeles and Van Nuys

o Implemented leadership development process including leadership competencies, individual development

planning, and succession planning

o Established a new Supplier Quality department structure and trained new personnel

o Implemented SMART Forms to mitigate/eliminate GDPs and non-conformances

o Improved Quality Receiving Inspection and Supplier Quality procedures to increase production and provide

standard work

o Implemented hand-held barcode e-solution for receiving raw materials

o Implemented advanced NIR equipment for ergonomic safety and chemical release cycle time reduction

o Implemented go/no-go gauges for various component inspection processes providing precision

improvements and cycle time reduction

o Partnered with Corporate and Division on continuous improvement ideas for Supplier Quality

o Completed Talent Review Process and Organization Inventory for all SE and SNE employees which drove

succession planning

o Successfully participated in multiple Regulatory Inspections with no Critical or Major Observations within

my scope of responsibility

Baxter Healthcare Corporation – Thousand Oaks, CA Sep 2000 – May 2010

Thousand Oaks Facility: ~750 employees

Quality Associate Manager Nov 2008 – May 2010

Supplier Quality, Receiving Inspection

• 2 direct SEE reports, 4 indirect SNE reports

Quality Associate Manager Aug 2007 – Nov 2008

Quality Systems, Change Control, Pest Control, Supplier Quality

• 3 direct SEE reports (2 indirect SEE report)

Managed 5 Quality functions and provided support to Manufacturing Operations. Updated/created procedures

and supported continuous improvement projects in support of improving quality systems, metrics and goals

Accomplishments:

o Feb 2009 – June 2009; Tampa, FL: Request of Baxter BioScience Division VP of Quality, Assisted Baxter

Medical Devices with investigations, CAPAs, Product Complaints and training to prepare for upcoming

Regulatory Audit

o Completed Baxter Lead Investigator Training and Certification for CAPAs

o Successfully provided coverage for 3 positions for 8 months (Change Control Associate Manager was a

vacant position and Quality Systems Associate Manager was on medical leave)

o Implemented new Supplier Quality department function, established organization and trained new personnel

o Implemented 5 S Lean Principles and established a Kanban system for office supplies

o Partnered with Corporate and Division on continuous improvement ideas for Supplier Quality

o Completed Talent Review Process for all SE and SNE employees which drove succession planning

o Successfully participated in multiple Regulatory Inspections with no Critical or Major Observations within

my scope of responsibility

Manufacturing Supervisor II Nov 2005 – Aug 2007

Supervised and trained multiple shifts in an ISO manufacturing setting. Updated and created procedures and

assigned to continuous improvement projects in support of improving manufacturing metrics and goals

• 12 direct reports (maximum 12 direct, 48 indirect reports on shift changeovers)

Accomplishments:

o May 2007 – Aug 2007: Request of Director of Quality, Assisted Quality department in a temporary

assignment on Supplier Quality, Change Control, and Pest Control functions

o Completed Talent Review Process for all SNE employees which drove succession planning

o Successfully participated in multiple Regulatory Inspections with no Critical or Major Observations within

my scope of responsibility

Manufacturing Associate IV / Lead Associate Nov 2004 – Nov

2005

Liaison to supervisor and manufacturing production daily activities on both shifts, provide support to

maintenance, calibration, and protocol activities in the manufacturing area, process continuous improvement

changes, lead 5S lean principles in the manufacturing area, EHS Representative

o 11 indirect reports (11 indirect on shift, up to 33 indirect reports on coverage days)

Accomplishments:

o Completed Lean Greenbelt Training on Lean Principles

o Established a Training Program and Schedule Rotation to optimize manufacturing schedule

o Implemented SMART Forms to mitigate/eliminate GDPs and non-conformances

Manufacturing Associate III / Shift Lead Mar 2004 – Nov 2004

Responsible for coordinating process schedules and events, act a representative for other departments, initiate and

facilitate work orders, initiate and close minor change control for process related issues, and train new personnel

o 5 indirect reports (5 indirect on shift, up to 15 indirect reports on coverage days)

Accomplishments:

o Implemented 5 S Lean manufacturing and established a Kanban system for office supplies and small parts

o Implemented Shift Communication Meetings and Daily Memos between all 4 shifts

Manufacturing Associate I-II Sep 2000 – Mar 2004

(Contract Employee Sep 2000 – Jan 2001)

EDUCATION

University of California Irvine – Irvine, CA

BS in Biological Sciences, June 2000

References Available Upon Request

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