Manager Quality
Resume:
Janina Navarro
*******.******@*****.***
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
Contact this candidate