Project Manager Quality Assurance

JEFFREY JOSEPHSON

818-***-**** ****.*********@*****.***

MANUFACTURING SUPERVISOR

PROFILE

Successful management experience in driving manufacturing operations,

comprehensive quality audits, supply chain functions, facility maintenance,

critical systems and enterprise solutions for a global manufacturer of

healthcare product lines. High-capacity track record in production

optimization, cost/safety controls, capacity planning, accurate reporting

and process improvements in fast-paced, high-pressure environments.

> Proficient as a top Project Leader, Process Champion and Change Agent in

all aspects of the production and quality assurance lifecycle from

strategic planning to tactical activities, along with procedural

analysis, internal controls, resource allocation, requirements

identification and vendor relationship building.

> Innovative development and implementation of successful quality audits

and high-impact training programs; rapid delivery of high-growth capacity

results and business efficiencies at multiple locations.

> Effective training, supervision and development of top-notch talent of

staff and management at a corporate production site for a Fortune 100

market leader.

> Self-motivated to achieve maximum productivity, maintain peak quality

service, ensure full regulatory compliance and meet aggressive business

objectives.

> Multi-tasking talents in team building, organization, needs analysis,

process improvements and attention to detail in time-sensitive

situations.

CORE COMPETENCIES

Manufacturing Operations ? Change Management ? Resource Allocation ?

Production Scheduling ? Quality Assurance ? Multi-Product Management ?

Strategic Planning ? Process Improvements ? Regulatory Compliance ?

Performance Metrics ? Technology Integration ? Cost Reductions ? Corrective

Actions ? Operational Streamlining ? Procedure Development ? Process

Validations ? Staff Training ? Site Inspections ? Out-of-Tolerance Reports

? Six Sigma Yellow Belt ? 5S/Kaizen Methodologies ? EHS ? cGMP ? ISO

Trainer ? JD Edwards ? Law Enforcement Officer ? Fortune 100 Work

Environments ? US Navy Veteran

EMPLOYMENT & ACCOMPLISHMENTS

Baxter Bioscience, Los Angeles, CA 2001 - 2013

Manufacturing Technician III, 2013

Primarily tasked with lowering bioburden levels in in-process product,

surface and environmental samples for average production of 12 lots per

week, representing $250,000 each, for major company facility. Trained and

led 5 staff in properly cleaning and sanitizing equipment, as well as the

production area, on a regular basis. Tracked and reviewed trends in

environmental and surface sampling results.

> Analyzed environmental and surface results and completed concentration

maps that were posted in the manufacturing area.

> Succeeded in reducing bioburden surface results by 50% within only 3

months over a goal of 25%.

Albumin Manufacturing Supervisor II, 2010-2013

In charge of managing a 20-person team in daily production operations,

along with job scheduling, materials handling, compliance, staff training

and auditing activities. Closely reviewed, approved and tracked

documentation for batch and system records. Helped in meeting product

release goals for final distribution. Represented the company during FDA

inspections, while demonstrating compliance with cGMP requirements.

Investigated and wrote Out of Tolerance (OOT) reports for the Manufacturing

Department.

JEFFREY JOSEPHSON Page Two

> Spearheaded $1 million in savings through continuous improvements to tool

management processes; also headed up a 20% increase in daily department

goals.

> Acted as subject matter expert (SME) for this department during Non-

Conformance Report investigations.

> Instituted a comprehensive tracking system for daily production goals.

Senior Operations Analyst - Continuous Improvement, 2008-2010

Responsible for facilitating large-scale enhancements through LEAN

manufacturing procedures focusing on Toyota Production Systems (TPS) in

order to reduce 7 different waste categories. Organized and conducted

failure mode investigations, root cause analysis, product impact and

corrective actions for exception reports.

> Served as Pharma SME for the "Shingo Award" process, resulting in a

Bronze medallion and a 34% overall improvement in plant efficiencies.

> Eliminated a backlog of over 1.5 million vials to avoid a global product

shortage and ensure timely delivery to over 10 countries; utilized

various methodologies, including 5S, Kaizen, visual metrics and others.

> Prepared detailed Value Stream Maps (VSM) that were presented at the

Baxter Bioscience Vienna conference in 2010.

Project Manager, 2007-2008

Managed a cross-functional team in transitioning such critical functions as

labeling, components, bills of materials and product inventory from

Lessines, Belgium to the Los Angeles facility for final processing and

shipping to Brazil. Assisted in administering Aralast filling and

packaging.

> Closely tracked and monitored BOM usage; guided change efforts to ensure

timely inventory messages.

> Facilitated and closed a Kaizen module for Albumin training.

Interim AHF-M Superintendent, 2006-2007

Provided hands-on ownership in driving daily production functions,

operational improvements and system refinements in the AHF-M process.

Directed supervisors in scheduling multiple shifts, administering budgets,

setting production goals, making staffing decisions and troubleshooting

different issues. Installed and validated new equipment and processes as

needed. Acted as departmental SME for internal and external audits.

> Key participant in a major project that expanded Hemofil-M yield by $20

million; also instituted standard work that reduced process time for

single suspension of Hemofil-M.

> Ensured that all manufacturing areas were in strict compliance with cGMPs

and EHS regulations.

> Collaborated with other departments to quickly identify and resolve any

equipment, process or compliance issues; also supported facility

maintenance and vendor relations.

AHF-M Manufacturing Supervisor II, 2001-2006

Built and oversaw a team of up to 20 Hemofil-M employees in all production

tasks, including product assembly, document review and preparation of

accurate batch records. Scheduled and facilitated bi-annual performance

reviews. Trained and oriented staff in operating policies and procedures.

> Achieved over $5 million in annual savings by heading up a special team

in reducing lot size and improving product yields.

> Designed and created a standard work map for the entire Hemofil-M

manufacturing process.

> Key participant as a subject matter expert in both internal and external

audits.

PROFESSIONAL TRAINING

- Baxter LEAN Certified Trainer/Facilitator; Baxter Certified Six Sigma

Yellow Belt; Baxter CAPA Certified Owner and Investigator.

- Proficient in MS Office Suite, JDEdwards, Kronos, Crystal Reports,

TrackWise, Minitab, DMAIC, RCA, VSM, FMEA, LIMS and other proprietary

applications.

JEFFREY JOSEPHSON Page Three

LAW ENFORCEMENT

Los Angeles Police Department

Police Officer

Coordinated all aspects of field law enforcement, including case

investigation, criminal apprehension, report generation, file updating,

community relations and street patrols, for the 2nd largest US city.

* Successfully completed the LAPD Academy among top 5% and received a

Police Science Diploma.

* Prepared and delivered over 1,000 investigative-type reports in a

timely and accurate fashion.

MILITARY

United States Navy

3rd Class Petty Officer/Aviation Ordnanceman

Responsible for inspecting, installing, maintaining and repairing the

armament system on A6, F18 and F14 aircraft, as well as ship's guns and

related equipment.

* Recipient of numerous medals and awards, including Sea Service

Deployment Ribbon, Defense Service Medal, Good Conduct Medal and others.

* Earned a commendation for achieving a 90% ready-to-issue rate for air

launch weapons division.

* Attended various technical schools, such as Strike Intermediate

Armament Maintenance and Intermediate Air Launch Missile weapon systems.

* Honorable Discharge.

Contact this candidate