Quality Control

Keyda V. Jones, M.B.A.

( **** Stone Bay Drive, Atlanta, GA ( Mobile: 704-***-****

(Email: *********@*****.***

EXECUTIVE SUMMARY

Quality Assurance professional with over ten years experience offering

expertise in the areas of staff supervision/training, operating, validating

and troubleshooting laboratory equipment.

DISTINCTIVE QUALIFICATIONS

. Relationship Management

. Self Motivated

. Excellent Verbal and Written Skills

. Proficient in MS Office

. Outstanding Mentor, Leader and Trainer

. Well Versed in Operating, Validating and Troubleshooting Laboratory

Equipment

PROFESSIONAL EXPERIENCE

Octapharma Plasma, Inc. Atlanta, GA 2009- Present

Regional Quality Director

. Responsible for the interviewing and hiring of Quality staff and

ensuring adequate center coverage for all regional centers.

. Conducts regularly scheduled staff, safety and quality meetings;

Ensures that the minutes are communicated to all center staff.

. Prepares for and hosts both internal and external audits; works with

the Center Director and Quality Supervisor to complete all audit

responses; ensures all audits are responded to and closed in required

time frames.

. Support the operations management in efforts to meet the region and

company goals.

. Analyzes tracking and trending data, determine appropriate actions

from this analysis to improve the trends.

. Implements, maintains, and monitors quality systems that would improve

quality in the product and services delivered/performed by the donor

center and to ensure compliance with all establishes SOPs, cGMP

requirements, and other applicable requirements.

. Assists in the technical writing of any Donor Center SOP creation of

forms and/or memos, and provide any other support necessary to

implement new/revised SOPs, as needed.

. Investigates and assists in developing corrective action propels; work

in conjunction with department management to review process, and take

appropriate corrective actions that may affect the safety, purity or

quality of the product or donor.

. Assists in the development and review of new and revised GMP operating

procedures

. Monitors compliance of all corrective actions to prevent recurrence

and perform checks to ensure effectiveness of actions.

International BioResources, LLC Tucker, GA 2008-2009

Quality Manager

. Provided direct supervision of the center Senior Quality Supervisors /

Quality Supervisors. Provides indirect supervision to Operations

management related to QA compliance in the Donor Centers. Monitored

center quality performance through direct and indirect contact, which

includes periodic on-site visits.

. Maintained thorough familiarity with all customer and regulatory body

requirements including but not limited to State and Federal

regulations, EU GMP regulations, OSHA regulations, Clinical Laboratory

Improvement Act of 1988 (CLIA) as applicable.

. Supported the center's ongoing Quality Supervisor training and

education through in-service sessions.

. Tracked all internal, customer and FDA audit findings to closure;

ensures that FDA audit Corrective Action Preventive Action dates are

met.

. Evaluated the adequacy and completeness of Exceptions Reports, using

available resources as needed. Investigated and proposes additional

corrective actions as required.

. Monitored center compliance with all applicable regulatory and SOP

requirements. Assists and directs the development of Corrective Action

Preventive Action Plans and effectiveness checks.

. Participated in ongoing internal, customer and regulatory audits of

donor centers. Ensures adequate preparation of Quality Supervisor

staff to participate/host audits.

. Assisted with ensuring that operating procedures are written at the

appropriate user level. Assists with the development and integration

of new/revised SOPs upon implementation.

. Supported the company's training goals through development of training

materials for SOPs or other training initiatives as determined by

Executive Management. Evaluates center systems to ensure best

practices that will drive and sustain compliance.

American Red Cross, NTL Charlotte, NC 2000-2008

Laboratory Technologist II, Nucleic Acid Testing 2002-2008

. Proficient with the Federal Code of Regulations, Current Good

Manufacturing.

. Analyzed tracking and trending data to determine appropriate actions

to improve trending.

. Practices, Standard Operating Procedures and Occupational Safety and

Health Administration standards.

. Determined validity of test batches that encounter errors during the

testing process.

. Participated in IQ/PQ/OQ Validations for equipment in the NAT

Laboratory.

. Team project member for the implementation of the Nucleic Acid Testing

(NAT) Assay.

. Worked with various Vendors to aid in the repair of equipment, which

has been removed from service.

Interim Lead Technologist, Nucleic Acid Testing Laboratory 2002-2003

(Appointed to interim position while simultaneously performing job duties

as Lab Tech II)

. Provided direction and leadership to Laboratory staff in the absence

of the general supervisor.

. Ensured that monthly staff meetings discussed SOP changes and

regulatory requirements were conducted, documented and minutes were

communicated to all department staff.

. Reviewed test records and verified test procedures were done in

accordance with Standard Operating Procedures and Local Operating

Procedures.

. Prepared staff and co-hosted both internal and external audits.

Collaborated with the department mangers to complete audit responses,

ensuring that all audits are responded to and closed in required time

frames.

Laboratory Technician I, Viral Immunology Laboratory 2000-2001

. Performed enzyme immunoassays procedures.

. Performed maintenance of Abbott Commander equipment, Ortho Summit

Hamilton Pipette's, Auto wash 360, and Dynamic Incubators. Used and

maintained Parallel Processing Centers as well as Abbott Flexible

Pipetting Centers. Generated equipment service repair reports.

. Reviewed test records and verified that test procedures were done in

accordance with Standard Operating Procedures and Local Operating

Procedures.

General Latex and Chemical Corporation Charlotte, NC 1997-2000

Quality Control Technician, Research & Development Laboratory

. Conducted chemical and physical analysis of raw materials.

. Assisted with in-process trouble shooting and overall production of

natural and synthetic lattices; to include making appropriate

viscosity, pH and total solids percentage adjustments.

. Prepared and maintained quality control data for raw materials and

lattices.

. Approved or rejected products upon completion.

Education

M.B.A. Management- Strayer University, Charlotte, NC

B.S. Biology -Francis Marion University, Florence, SC

References Available Upon Request

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