Position Title: Document Specialist III
Work Location: Illinois, USA 60064
Assignment Duration: 11+ months
Work Schedule: 8 AM - 5 PM
Work Arrangement: Onsite
Position Summary:
The primary function is to review and process document change request packages to maintain necessary division level documentation consisting of policies, procedures, and/or product specifications.
Function in an advisory role regarding document management and change control practices.
Key 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 to established procedures.
* Interact with change request initiators and approvers to resolve 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 to areas of expertise. Complete special projects and routine work on schedule.
* Maintain documents and data according to standard operating procedures.
* Provide guidance to stakeholders in the understanding of the QSD structure or change control process. Provide technical writing support to subject matter experts and change request initiators.
* Convey technical expertise via solid written and oral communication.
* Must be able to rearrange priorities on short notice to react to (internal) customer needs and / or provide audit support.
Qualification & Experience:
* Bachelor's degree is preferred. A major or minor in a scientific discipline is highly desirable.
* 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 to effectively communicate with change originators and other Documentation Services staff in the organization. Ability to work in a geographically diverse business environment.
* Must know correct English grammar and syntax.
* Good people relations, able to work independently with good administrative and time management skills. Able to contribute to a department or cross-functional problem-solving team
* Must be able to perform detailed, careful work, including proofreading of numerical values, equations, etc.
* Ability to resolve differences among various departments to assure that proposed changes follow the Plant, Division, and Corporate guidelines.
* Ability to complete tasks under Management supervision.