Jobs

Description

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 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 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.