Quality Coordinator Resume

SUMMARY

Education

M.Ed., Education
B.S., Applied Human Science

Professional Experience

Confidential,
Johnson City, TN Quality Coordinator Jun 2009 - Present
Project Manager Oct 2008 – Jun 2009
Quality Coordinator Apr 2007 – Oct 2008

Quality Coordinator:

Monitors each study to assure management that facilities, equipment, personnel, methods, practices, records, and controls are in conformance with government regulations and standard operating procedures.
Inspects each study at intervals adequate to assure the integrity of the study and maintains written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection. Any problems found during the course of an inspection which are likely to affect study integrity are brought to the attention of the project manager and management immediately.
Determines that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
Monitors GCP and 21 CFR 11 training programs for all staff.
Monitors that all staff are trained and competent to perform all assigned tasks
Ensures that validation protocols are designed prospectively, performed, and evaluated, written, and approved prior to implementation.
Ensures that quality planning is formalized, ongoing, and continuous.
Maintains the Quality Plan.
Ensures that the quality of services provided conforms to regulatory, customer, client, and company standards.
Periodically submits to CEO written status reports on each study, noting any problems and the corrective actions taken.
Reviews CAPAs to ensure corrective and preventative actions are appropriate and completed.

Project Manager:

Ensures that all laboratory responsibilities outlined within the protocol are carried out in an efficient and professional manner and in compliance with laboratory policies.
Determines supplies required for investigator kits. Provide quality assurance oversight to the assembly process.
Creates training materials for investigators and internal staff.
Develops protocol and visit specific requisitions.
Interfaces with laboratory, customer service, business development, external project management, and information technology and data management personnel.
Represents LabConnect at investigator meetings.
Serves as the primary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules are followed.
Updates project status to supervisor.
Coordinates specimen transfer and reporting with external referral laboratories.
Assures new clinical test procedures and new IT database validations are completed and acceptable prior to specimen receipt and reporting for specific project.
Assures all investigator site information is validated in applicable databases.
Participates in internal quality assurance unit.
Reviews project design and development with supervisor.
Performs other related duties and tasks as necessary or as assigned.

Shipping Clerk:

Prepared clinical trial materials kits and performed shipping duties.

Confidential,Bristol, TN Quality Control/Auditor Feb 2006 – Apr 2007

Quality Control:

Inspected product for cosmetic and functional defects and for personal data.
Utilized quality documents and work instructions to ensure product meets client specifications.
Documented quality technician product failures and addressed with quality technician.

Auditor:

Inspected products which have undergone quality control checks.
Utilized quality documents and work instructions to ensure product meets client specifications.
Documented quality control failures and addressed with quality control personnel.

Confidential,Bristol, VA Assistant Office Manager Nov 2005 – Feb 2006 Front End Manager May 2004 – Feb 2006

Assistant Office Manager:

Compiled end of day and weekly store sales reports.
Oriented new hires.
Addressed payroll and human resource issues.

Front End Manager:

Documented training of employees.
Managed store front end employees.
Managed cash office.
Prepared end of day front end sales reports.

Confidential,Bristol, VA Customer Service Rep Apr 2001 – Jun 2003

Customer Service Rep:

Utilized troubleshooting software to identify product issues.
Addressed customer complaints while using sales techniques to enhance the customer’s service plan and explained billing practices to customers.
Balanced needs of customer with the needs of the business when customers demanded invoice adjustments.

Confidential,Bristol, TN Customer Service Rep Aug 1998 – Jun 2000

Customer Service Rep:

Answered medical and dental benefit and eligibility questions.
Explained claim processing details.

Computer Experience

Microsoft Office (Word, Excel, PowerPoint)
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