Robert Bartley Email & Phone Number

Plattsburgh, New York, United States

Plattsburgh, NY

Plattsburgh, New York

Manage and maintain compliance program for continued certification to ISO 9001 and 14001 standards for a point of sale solution provider. Participate in the design of, and oversee the implementation of, the internal corrective and preventive action program used as a tool for continual improvement. Manage the internal audit program, conduct internal audits.

Review and approve work of analytical chemists to ensure accuracy, completeness, and compliance with internal requirements and Good Laboratory Practices. Conduct department specific audits in the Formulation and Analytical units of Drug Safety. Analyze dose formulations by high performance liquid chromatography in support of Pre-clinical Safety Assessment.

Independently conduct audits for Pre-clinical Safety Assessment studies for regulatory submission. Audits performed include: Study-specific Audits, Process Audits, Systems Audits and audits of contract research organizations and other Wyeth sites.

Designed and conducted mouse micronucleus studies to support regulatory submissions. Responsibilities included; protocol development, study conduct including microscopic evaluation of bone marrow, and final report writing.

Performed pre-clinical toxicology study activities in accordance with study protocol, standard operating procedures and Good Laboratory Practices.

Performed high performance liquid chromatography assays to determine strength, content uniformity and purity of test compounds in accordance with Good Manufacturing Practices.

Bs, Biological Sciences

Aas, Ecology And Environmental Technology

Education record

Education record