Document Specialist III

Description:
The primary function is treview and process document change request packages tmaintain necessary division level documentation consisting of policies procedures and/or product specifications. Function in an advisory role regarding document management and change control practices.

Major Responsibilities:

• Review change request packages and documentation for assigned document types. This may include but is not limited to: product manufacturing packaging and testing and quality system documents. The incumbent ensures that any changes made are documented justified and approved by the required functional areas according testablished procedures.
• Interact with change request initiators and approvers tresolve discrepancies. Utilize various software programs for document review cross-referencing and distribution. Support use of change control systems including providing training resolving questions and proposing changes/improvements.
• Provide assistance on projects according tareas of expertise. Complete special projects and routine work on schedule.
• Maintain documents and data according tstandard operating procedures.
• Provide guidance tstakeholders in the understanding of the QSD structure or change control process. Provide technical writing support tsubject matter experts and change request initiators.
• Convey technical expertise via solid written and oral communication.
• Must be able trearrange priorities on short notice treact t(internal) customer needs and / or provide audit support.

Education:

• Bachelors degree is preferred. A major or minor in a scientific discipline is highly desirable.
• Background:
• Minimum of 2 years of Nutrition Device Pharmaceutical or other health care/industry experience in related operations areas such as manufacturing materials management quality control quality engineering document control compliance auditing engineering and/or regulatory.
• Knowledge of regulations and standards affecting documentation and system requirements. Knowledge of cGMPs.
• Knowledge of policies and procedures impacting documentation and documentation practices.
• PC and Microsoft Office experience
• Strong verbal and written communication skills with ability teffectively communicate with change originators and other Documentation Services staff in the organization. Ability twork in a geographically diverse business environment.
• Must know correct English grammar and syntax.
• Good people relations able twork independently with good administrative and time management skills. . Able tcontribute ta department or cross-functional problem-solving team
• Must be able tperform detailed careful work including proofreading of numerical values equations etc.
• Ability tresolve differences among various departments tassure that proposed changes follow the Plant Division and Corporate guidelines.
• Ability tcomplete tasks under Management supervision.