Document Control Specialist I

Main Purpose 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.

Responsibilities 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

Knowledge, Skills, and/or Abilities: Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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

Education And Experience 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.

• Pay range: 20-26/hr DOE