CURRICULUM VITAE

Robert A. Stone

*** ********* ****

Griswold, CT 06351

Email: acvms7@r.postjobfree.com

860-***-****

OBJECTIVE

To obtain a position in Quality Management that will utilize the managerial, supervisory, laboratory skills and knowledge of cGMP and ISO 9000 regulations that I have obtained from both my extensive work experience and education.

PROFESSIONAL EXPERIENCE

Tower Laboratories, Ltd January 2008 to April 2016

Centerbrook, Ct

Position: Compliance Manager

Duties and Responsibilities: Ensure corporate compliance to FDA cGMP regulations in

Drug, Medical Device and Dietary Supplement manufacturing. Conduct internal audits of cGMP as to ensure compliance to cGMP and corporate internal procedures and policies. Direct Lead during FDA inspections and Customer audits. Responsible for all FDA correspondences and filings. Interpret regulations and maintain an awareness of industry trends on compliance issues. Respond to all customer complaints. Issue summarizations and trend analysis reports of all complaints on a quarterly basis to the President of Tower Laboratories, Ltd and Key Personnel. Perform cGMP trainings, deviation and OOS investigations, validation protocol review, and change control activities.

Tower Laboratories, Ltd. November 2002 to January 2008

Centerbrook, Ct

Position: Quality Assurance Manager

Duties and Responsibilities: Manage the Quality Assurance Department to ensure the

companies compliancy to cGMP regulations in both drug and medical device

manufacturing. Review manufacturing batch records and QC testing data to ensure

conformance to approved procedures and cGMP practices. Perform batch/lot release of

final product. Conduct internal audits of cGMP as to ensure compliance to cGMP and

internal procedures and policies. Conduct external audits of raw material vendors,

contract laboratories, and contract service providers. Direct Lead during Customer audits

and FDA inspections. Responsible for all FDA correspondences and filings. Perform

cGMP trainings, deviation and OOS investigations, validation protocol review, and

change control activities. Interpret regulations and maintain an awareness of industry

trends on compliance issues. Respond to all customer complaints. Issue summarizations

and trend analysis reports of all complaints on a quarterly basis to the President of Tower

Laboratories, Ltd and Key Personnel. Manage a staff consisting of a QA supervisor,

Document Control Specialist, and six QA Inspectors.

Tower Laboratories, Ltd. October, 2001 to November 2002

Centerbrook, Ct

Position: Document Control Specialist

Duties and Responsibilities: Control all Documentation in accordance to cGMP (Drug &

Medical Devices) regulations associated with daily manufacturing of effervescent products. Wrote, edited, reviewed, approved and distributed all standard operating procedures. Maintained all Master SOP Manuals, SOP History files, Master Batch

Production Records, Product Component & Raw Material Specifications Test Records

and Final product Specifications. Generated IQ, OQ, PQ validation protocols as well as

general validation procedures. Reviewed Batch Production Records and released final

product. Maintained customer complaint files, responded to each complaint in a timely

manner and issued quarterly reports to the President of the company.

Charles River Laboratories – SPAFAS Division March, 1992 to June, 2001

Storrs, Ct

Position: Technical Services Manager/ Document Control Specialist

Duties and Responsibilities: Manage and direct personnel and operations involved in the

health monitoring and certification of SPAFAS’ SPF poultry flocks as outlined in both

the European Pharmacopia (EP) and the USDA Memorandum 800.65, preparation and

quality control of SPF Chick Embryo cell cultures and medias, quality control testing and

release of SPAFAS produced Avian antigens and antiserum, and contract testing services. Control and coordinate all activities within the Technical Services Department. Prepare and maintain SPF flock testing schedules for all locations including international per forecast. Hire, review, train and develop Laboratory Technicians for future growth

within the organization and assign responsibilities consistent with individual strengths.

Operate under and maintain ISO-9002 certification and cGMP guidelines. Assure all

processes are performed in accordance with approved standard operating procedures.

Maintain all Laboratory Technicians training files/records. Review, record, and sign off

all testing documentation. Assist Quality Assurance Manager with all customer audits

associated with the laboratory facility. Schedule and maintain all equipment calibrations and maintenance files. Evaluate, specify, install, and validate new laboratory equipment as needed. Generate commercial test reports and maintain all records. Responsible for creating the budgetary needs and operate under the approved budget. Increase annual departmental sales and decrease operational costs following corporate guidelines.

Charles River Laboratories – SPAFAS Division March, 1989 to March, 1992

Storrs, Ct

Position: Supervisor of Serology Laboratory

Duties and Responsibilities: Supervise daily activities and laboratory technicians within

the serology laboratory. Plan, coordinate and schedule the activities

of the serology laboratory. Perform testing on commercial/contract submissions. Carry

out routine laboratory tests for the monitoring and certification of SPAFAS’ SPF poultry flocks. Perform such tests as ELISA, HA-HI, IFA, AGP, SPA, MNT, and SN. Assist in reviewing current and new departmental procedures.

SPAFAS, Inc. June, 1987 to March, 1989

Storrs, Ct

Position: Laboratory Technician

Duties and Responsibilities: Perform quality control testing on SPAFAS’ SPF poultry flocks. Carry out routine laboratory functions. Operate and maintain Poultry (FAPP) building. Schedule and carry out various antiserum projects. Supervise and perform routine functions in the Packing and Shipping Department.

EDUCATION

State University of New York 1981 to 1983

Agricultural and Technical College

Canton, New York

A.A.S. Degree in Veterinary Science Technology

ACHEVIEMENTS/AWARDS

Improvement Through Teamwork Award (Charles River

Laboratories Values Award Program) 1999

HOBBIES and INTERESTS

Camping, Hiking, Biking, Canoeing, Gardening, Landscaping, Reading, Traveling

References available upon request

Contact this candidate