Quality Assurance Control

Professional Experience

**** ** **** ****** *******, LLC

Quality Systems Consultant, R.J. Reynolds Tobacco Company, Product

Integrity - Clinical Studies Division, Winston Salem, NC.

. Defined the structure for the client's quality system and supporting

compliance policies, programs and procedures including administrative

SOPs; clinical study conduct, project management, data management and

quality assurance SOPs.

. Responsible for writing and/or review of SOPs, supporting templates,

corporate quality program, and FDA preparedness policies.

. Created training materials to support the program initiative and SOP

content including the incorporation of relevant FDA warning letters.

Conducted training on SOPs and relevant International Conference on

Harmonisation (ICH) Guidances, FDA Guidances, Good Clinical Practices

(GCP) and Good Laboratory Practice (GLP) regulations.

. Maintained an up-to-date project schedule to reflect bi-weekly progress.

Quality Systems Consultant, Reynolds American Incorporated Services

Company (RAISC), Winston Salem, NC.

. Created a robust and defendable compliance program to support alignment

in training requirements (GCP, GLP and cGMP) throughout RAISC and its

operating companies including the development of corporate level

training, Learning Management System SOPs and work instructions.

. Developed process mapping of corporate wide training requirements and

defined consistent regulatory language in efforts to align training

requirements.

. Maintained an up to date project schedule to reflect bi-weekly progress.

2003 to 2008 Science and Engineering Group (SEG), RTI International,

Research Triangle Park, NC.

QA Manager, Quality Assurance Unit (QAU) (August 2006 to October 2008;

Acting QA Manager June-July 2006).

. Provided leadership, management, and direction to achieve quality and

compliance objectives. Implemented and sustained an "industry quality

standard" infrastructure which promoted commercial and government

business.

. Ensured high quality and efficient compliance with GLP (FDA, EPA and

OECD), GCP, cGMP operating standards and Quality System Regulations as

applicable.

. Anticipated organizational quality system needs, and then developed and

implemented effective solutions.

. Established and maintained regulatory compliance systems for the

evaluation and validation of computerized systems, including GxP

laboratory instrumentation systems and managed validation change control

processes.

. Managed QA department staff, provided oversight of the development and

implementation of SOPs, interacted with clients during inspections and

qualification visits, developed and implemented GLP and cGMP training

programs, provided senior management with tracking tools for monitoring

regulatory compliance, and monitored group-wide quality improvement

initiatives.

. Performed routine managerial duties, including budgeting, resource

allocation, and staff management and development for a department of

seven QA professionals.

Research Natural Sciences QA Specialist 1, QAU (December 2004 to July

2006).

. Assisted the QA manager in performing administrative duties within the

QAU, including scheduling work, providing technical oversight of

toxicology QA staff members, and training staff. Presented regulatory

compliance training for technical staff.

. Responsible for inspecting critical phases, auditing raw data and final

reports for RTI's toxicology, DMPK, environmental sciences, analytical

laboratories and validation activities to assure compliance with

applicable regulations (FDA GLP, GCP or cGMP, EPA GLP, international GLP

regulations (Organisation for Economic Co-operation and Development

[OECD]).

. Participated in hosting FDA and EPA site visits. Hosted commercial site

visits as well as performed external site visits for compliance

assessment.

Quality Assurance Specialist 3, QAU (February 2004 to December 2004).

. Responsible for regulatory compliance review and QA for SEG's Health

Sciences Unit. Monitored work under FDA/EPA/OECD GLP regulations and

principles.

. Reviewed SOPs, protocols, and inspected facilities, processes, and

critical phases to assure compliance with FDA, EPA, and OECD GLP

requirements.

. Provided full QA support for complex projects. Audited raw data and final

reports for developmental toxicology and reproductive toxicology studies,

as well as those for analytical work in support of toxicology studies.

. Participated in client site visits. Trained and mentored less-experienced

QA staff.

Quality Assurance Specialist 2, QAU (July 2003 to January 2004).

. Responsible for regulatory compliance review and QA for SEG's Health

Sciences Unit, formerly Chemistry and Life Sciences Group. Monitored work

under FDA/EPA/OECD GLP regulations and principles.

. Reviewed SOPs, protocols, and inspected facilities, processes, and

critical phases to assure compliance with FDA, EPA, and OECD GLP

requirements.

. Audited raw data and final reports for developmental toxicology and

reproductive toxicology studies, as well as those for analytical work in

support of toxicology studies. Assisted in training less-experienced QA

staff.

Quality Assurance Specialist 1, QAU (January 2003 to June 2003).

. Assisted QA Specialists 2 and 3 who were responsible for regulatory

compliance review and QA for the Chemistry and Life Sciences Group.

. Audited GLP documentation through reviews of SOPs and protocols, process

inspections, and audits of raw data/ final reports for developmental

toxicology and reproductive toxicology studies.

1996 to 2001 Merial Select, Inc., Raleigh, NC.

Quality Control Supervisor/Raleigh Site Safety Coordinator (February 1999

to August 2001).

. Responsible for supervision of quality control (QC) testing unit for a

staff of five in a current Good Manufacturing Practices (cGMP) poultry

vaccine facility.

. Responsible for product testing and release, product comparison testing,

efficacy and stability testing for inactivated poultry vaccines,

departmental SOPs and training.

. Reviewed testing records and maintained historical records for vaccine

component performance.

. Raleigh site safety coordinator duties included determining appropriate

PPE for tasks, stock of PPE, MSDS maintenance in 3 facilities, revisions

to vaccine MSDS', adherence to applicable OSHA regulations, led safety

inspections of facilities and reporting any findings to management,

accident investigation and reporting as well as prevention, developed and

conducted site safety training as needed, represented site at corporate

safety meetings and implemented corporate safety initiatives.

Quality Control Associate (August 1996 to January 1999).

. Responsible for product QC testing including microbiological and animal

testing (e.g., ELISA, Efficacy, Sterility), and animal husbandry.

. Coordinated with marketing staff to design/ implement mock field trials

of inactivated vaccines for blinded comparison.

. Safety team member.

Education

B.S., Biology, Chemistry Minor, University of North Carolina at Charlotte,

Charlotte, NC, 28223, 1996.

Certifications

Registered Quality Assurance Professional-Good Laboratory Practices (RQAP-

GLP), Society of Quality Assurance, May 2006. Re-registration approved

December 2009 and December 2012.

Continuing Education

SQA Good Clinical Laboratory Practices (GCLP) Auditing Webinar October 26,

2012

SQA Regulatory Forum Webinar October 01, 2012

SQA Peer to Peer Mentoring Program Member September 2012 to present

WebWise Learning Overview of ICH GCP and Recruitment and Selection of the

Good Clinical Practice Fundamentals E-learning program, April 2008

GLP Regulations Refresher and Part 11 Requirements: Being Prepared for the

FDA Audit presented by E. Krohl of EHKrohl Consulting, Inc., RTI, Research

Triangle Park, NC, May 31, 2007

SQA Annual Meeting, the Society of Quality Assurance; May 2007, October

2003

Good Manufacturing Practice (GMP) Online Refresher Training; March 2008,

April 2006

GAMP Training for Quality Assurance Professionals, presented by A. Simkins

of NCCSQA, GSK, Research Triangle Park, NC, March 27, 2007

Analytical Instrument Qualification Audio Seminar presented by L. Huber

(CD) from LabCompliance, RTI, Research Triangle Park, NC, February 06, 2007

Computerized System Validation and Part 11. Presented by R. Geiger (CEO of

InfoStrength, Inc.), RTI, Research Triangle Park, NC, November 19, 2004

Understanding and Auditing of Statistics and SAS. Presented by NCCSQA,

Research Triangle Park, NC, November 4, 2004

Professional Organizations

North Carolina Chapter of the Society of Quality Assurance (NCCSQA) 2004 to

2009, 2012

Society of Quality Assurance (SQA) 2006, 2007, 2008, 2012

References/ transcripts available upon request.

Contact this candidate