This section focuses on the main purpose of the job in one to four sentences. Review and approve GMP/GLP Manufacturing and related documentation to support timely product and system release. Conduct internal audit of SOPs, training records, and other document types on an as needed basis. Assist and guide engineering in the preparation of product documentation, product configuration and document change request package development. Responsible for activities related to providing required documentation and implementing related documentation systems. Assist in providing training on documentation and labeling processes and systems. Participate on project teams as needed.

This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.

The incumbent will perform other duties assigned.
Document configuration and product data management
Aid in the execution of user acceptance testing
Aid in the creation/writing of training materials
Assist in training internal and external personnel on documentation and labeling related processes and systems
Maintain and own internal documents
Review documentation for accuracy and compliance to procedures. Route, release or reject as appropriate. Ensure all document and system elements are identified, accurate and assembled for review and approval.
Maintain, proof read, and change as needed Standard Operating Procedures To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

Product/document configuration. Intermediate level and document management (e.g. Word) software skills

Project Management Skills
Must have excellent conceptual, analytical, written and verbal configuration skills
Comprehension of design methodology, product configuration and complex manufacturing processes
Ability to work under strict deadlines and changing priorities with minimal supervision
Strong interpersonal skills and great attention to detail are necessary
Must be a strong team player with good problem solving, and good verbal and written communications skills
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Applications of Good laboratory Practices, and Application of Good Manufacturing Practices Include the education and experience that is necessary to perform the job satisfactorily.
B.A. or B.S. and 3-5 years related experience (in-house or acquired outside).
Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
Knowledge of product/document configuration management.
Working knowledge of related business systems.

Notes:

1st Shift - 8AM to 5PM - Wednesday to Sunday