PURPOSE AND SCOPE:

Responsible for representing the sites quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning for the facility.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

+ Under close supervision, utilizes established procedures to perform routine assigned tasks and applies company policies and procedures to participate in the development, review, and improvement of the facility's Quality Plan and manufacturing processes. Participates in management of product Risk Management Files. Continually updates information and coordinates information exchange with other FMCNA facilities.
+ Utilizes current acceptable industry/FDA requirements to justify, write, and implement process validation and GMP procedures. Drafts, reviews, and/or assists in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders ...