Documentation Specialist

Position Title: Documentation Specialist
Work Location: North Chicago IL 60064
Assignment Duration: 06 Months

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.
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 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.

Education:

•  Bachelor’s or Associates degree is required.

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 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.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $25.00/hr – $27.00/hr.