Quality Assurance Specialist

Ell-Sean Smith, MBA

PROFILE:

MBA Professional with extensive process mapping, report writing, and improvement strategies experience as it relates to quality and compliance.

Proficient in meeting complex workflow challenges, investigations, and managing disputes. Proven abilities in monitoring, regulatory compliance, compliance auditing, quality assurance/control, process improvement, project management, and managing sources of significant conflict or change. Also, possesses strong analytical and problem solving skills, proficiency at streamlining operations that increase efficiency, and improving overall product quality.

Recognized as an effective communicator, able to present at all levels; capable of forming and maintaining positive and productive working relationships in internal, external, independent, and team environments.

OBJECTIVE:

Seeking employment with a Progressive Organization or Service that will fully utilize my education and experience thus allowing for the opportunity to further my skills and contribute to the collective goals of the Business.

SOFTWARE/APPLICATIONS:

MS Visio • MS Access • MS Powerpoint • MS Office Suite • SAP

EDUCATION:

Texas A&M University

Doctorate of Education candidate

8/2008 - Present

University of Phoenix, Walnut Creek, CA

Masters of Business Administration

Completed June, 2003

California State University, Hayward, CA

B.A. Political Science/Public Administration

Completed June, 1998

Ell Sean Smith’s resume

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PROFESSIONAL EXPERIENCE

Bayer Healthcare, Berkeley, CA 06/2000 – 12/2007

Process Quality Specialist IV

• Responsible for operational and compliance audits in accordance with State and Federal Regulations, Policies, and Procedures.

• Rejected and provided analysis of outbound products pending disbursement.

• Presented key findings of analysis and compliance reports to Senior Management as needed.

• Contact for issue management and resolution.

• Prepared weekly, monthly, and annual Product and Deficiency Review reports.

• Analyzed workflows and recommend process improvement opportunities.

• Analyzed manufacturing batch records for completeness and to ensure compliance with cGMP’s and FDA regulations and procedures.

• Provide training as needed and keep track of individual training needs including follow-up with Senior Leaders.

• Escalated documents requiring corrective actions to appropriate department.

• Final authority on all product releases to Medical Centers and Pharmacies

• Performed department safety inspections for compliance and training when needed.

• Manage all files, records, and validation sheets associated with operational and compliance audit.

Kelly Scientific, Walnut Creek, CA

Consult: Sequoia Analytical, Inc., Walnut Creek, CA 01/2000 - 6/2000

Project Manager

• Developed project plans, identified and assigned resources, and managed budgets.

• Provided project status to all team members and functional area managers

• Reviewed analytical test results.

• Coordinate QC Testing with outside agencies (i.e. Chevron, Tosco)

• Reviewed new and revised SOPs, Protocols and Reports, Test Methods, and specifications requiring QA review/approval.

• Trained and supervised daily activities of the QC Analysts.

Time off to complete Bachelor's degree. 01/1998 – 01/2000

REFERENCES:

Provided upon request

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