Senior Documentation Specialist-Document Control & Change Management

Documentation Specialist

Required Education• Associates degreePreferred Education• Bachelor's degreeRequired Experience• 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

Overview (Documentation Specialist)

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.

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

**Only those lawfully authorized to work in the designated country associated with the position will be considered.**

**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**