JOB RESPONSIBILITIES
Executes the initiation, processing, routing, and archiving of cGMP documentation related to global specifications and methods.

Manages and updates commercial specifications and methods (internal release, stability, regulatory and compendial), and supporting documents for all drug products, drug substances, intermediates, starting materials, excipients, reagents, and packaging components.

Reviews and executes change actions for Global Testing Standard documents.

Ensures alignment of department procedures with global and site policies and procedures.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

A minimum of 4 years of relevant experience, direct document management experience in a regulated environment focused on product quality is preferred.

Strong teamwork, time management, organizational and communication skills, and the ability to follow written and verbal instructions are required.

Excellent computer skills and knowledge of MS Office and Document Management systems is required.

Detail-oriented with a quality mindset.


Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a relevant industry.

Experience in providing guidance on compliance-related issues.