Quality Assurance Training

ExperiEnced biotechnology/ pharmaceutical professional

Qualifications Summary

I am an analytical, detail-oriented, data driven and dynamic professional,

offering 9+ years of comprehensive international, hands-on leadership

experience in quality, supplier quality management, sterile manufacturing,

investigations & CAPAs, change controls, gap analysis, SOP creation and

revision, continuous improvement, Lean/ Six Sigma training, compliance/

cGMP training, business operations analysis, QMS design and development,

project planning, program monitoring and evaluation. My experience has

allowed me to influence management and operations without the use of

authority in order to drive compliance and deliver business goals.

Areas of Expertise

Quality Assurance and Regulatory Compliance Project Management and

Development Continuous Process Improvement

Lean/ Six Sigma Certified Conflict Resolution and Decision-Making

Strategic Planning and Implementation

Cost Optimization and Budget Control New Process Introduction

Professional Experience

J. Ross allen & associates, inc. 2013 - PRESENT

Co-Officer and Senior Consultant

SOUTH INDIAN PHARMACEUTICAL COMPANY: Manufacturing Quality Assurance

05/13 - 3/14

. Manufacturing Quality Assurance operations oversight / remediation

support

. GMP / GDP auditing of Manufacturing, Warehouse, Events and Maintenance

activities

. FDA inspection preparation

. Final batch record review for US batch release, production and

analytical documentation

. Daily, real-time aseptic technique monitoring

. Daily clean room auditing

. Mentoring of production and quality assurance personnel on proper

application of cGMPs

. Training, Evaluation and Certification of site Manufacturing Quality

Executives for cGMP Compliance

NORTH INDIAN PHARMACEUTICAL COMPANY: Quality Assurance

01/13 - 04/13

. Complete Batch Record Review and approval of internationally

manufactured (Asia) generic pharmaceuticals for US market release

. GDP / GMP training

. On-site review of records and operational activities to provide GMP

and process improvement related recommendations

Pharmavite, LLC, San Fernando, CA 2011-2012

Continuous Improvement and Training Supervisor / Assistant manager - Soft

Gel and Tableting

Provide strategic leadership and supervision in the development and

execution of improvement programs throughout the organization. Work and

oversee all phases of quality, operations, finance and planning to leverage

supply chain with the Leadership Team. Design and develop strategic

improvement plans for the succeeding year, including risk mitigation and

contingency plans.

. Trained employees and managers on Lean philosophy

. Guided and managed Lean projects implemented in operations

. Auditing production activities for compliance and improvements

. Spearheaded Lean training and implementation in the scheduling group

. Worked as part of a cross functional team to identify and implement

Lean principles in the ERP data reporting system for the CFO

. Part of a team that identified the root cause of the creation of $15-

20M in obsolete inventory per year

. Implemented cross functional statistical software requiring the

integration of network servers and user licenses

. Trained supervisors and managers on basic and advanced problem solving

skills

. Auditing corrective action for completeness and effectiveness

. Defined and proceduralized the QA and operations deviation process

. Created quality standards for Soft Gel automated inspection equipment

. Successfully generated 52% reduction of cross-contamination

. Developed site process map

. Analyzed and modified the corrective and preventative action process

. Identified and implemented 50% more improvement projects than planned

. Conducted factory acceptance test on new equipment

. Created an organizational value stream map, from receiving to customer

receipt

. Redefined key performance indicators to better understand the

condition of the business

. Spearheaded improvement projects valued at $300K and $5M

. Member of the corporate emergency response & disaster recovery teams

. Revised and created SOP's and job instructions for floor operations

Amgen Inc., Various Locations / Fremont, CA 2005-2010

Purification Associate

. Managed the implementation of best practices, which resulted in a 25%

reduction in documentation errors and a 30% decrease in document

review time

. Eliminated redundant and unnecessary documentation in site procedures

by approximately 60% as part of a cross-functional team

. Batch record review

Commercial and Clinical Packaging / Fermentation / Cell Culture

Manufacturing Associate

. Group ERP subject matter expert

. Team lead for implementation of electronic batch records

. Production supply area inventory and auditing specialist

. Process owner and trainer for clinical packaging operations

. Sterile cell culture processing

. Operations risk assessor

. Owned and lead investigator for non-conformances, CAPA and

effectiveness verification on past corrective actions

. Batch record review

. Revised, created and approved SOP's for new procedures and operations

. Reduced inventory discrepancies by over 50% through the application of

new MES/SAP systems and the strategic use of Six Sigma and Kaizen

principles; increased production capacity by 15%

. Equipment and process validation

. Technology transfer

. Facility restart post 5 year shutdown

Quality Assurance Associate

. Owned and lead investigator for non-conformances, CAPA and

effectiveness verification on past corrective actions at local and

international sites

. Proactively organized change controls to minimize and/or prevent

shortage of approved materials

. Collaborated with vendors to resolved supplier quality issues and raw

material discrepancies as a supplier quality representative

. Communicated status of high priority issues with senior management of

QA, Regulatory, and Research and development

. Created/ revised SOP's & raw material specifications

University of California Santa Barbara, Santa Barbara, CA 2003-2005

Laboratory Assistant-Vector Researcher

Managed and maintained the cleanliness of the laboratory by sanitizing

materials, preparing for laboratory experiments, disposing hazardous

materials and maintaining laboratory equipment.

Other Experience

Woodard's Todai Dojo, Moorpark, CA 2001-2003

Martial Arts Instructor

Volunteered to train and instruct students of all ages on the use and

application of martial arts principles.

Education

Master of Business Administration and Master of Science in Biotechnology

(on hold)

California State University, Channel Islands, Camarillo, CA

Bachelor of Science in Cellular and Developmental Biology (2005)

University of California Santa Barbara, Santa Barbara, CA

Professional Training

Lean/Six Sigma Green Belt

Project Management

Leadership Skills Development

Corporate Emergency Response

Corporate Disaster Recovery

Awards and Honors

Spotlight on Quality Award

Technical Skills

Microsoft Office Suite (Word, Excel, PowerPoint, Project, and Visio),

Minitab, JDE, SAP, MES, and Cetova

Contact this candidate