Job Description

Who we want

* Dedicated focus. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
* Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information and revise and create processes to maintain and develop best practices.

What you will do

As a Document Control & Configuration Specialist you will interact with cross functional teams that collaborate on development, review and release of products and make decisions based on quality system regulations and requirements. As a member of this team you will, under minimal supervision, interact and collaborate with document creators and reviewers to evaluate and judge accuracy and completeness of DMR documentation, Bills of Material and change paper within corporate procedure and GMP requirements. This includes administering the documentation aspects of engineering change management, responsibility for the accuracy and reliability of the document data bases, and the maintenance of hard copy and electronic DMR files.

* You will prioritize daily tasks to support the business and customers in the distribution and selling of products.
* You will administer the DMR, Specifications, Change Orders, Parts and Bills of Material, through the release and distribution processes in accordance with corporate and department documentation procedures and guidelines.
* You will provide leadership, training and technical support within the document center and to other user groups in the administration of the DMR system.
* You will be responsible for archiving and retrieval of historical DMR files in accordance with defined filing standards, record retention policies and GMP.
* You will support DMR vault and archive files through proper DMR management.
* You will be responsible for training users on various systems and processes as needed, including technical support to customers and other department staff.
* You will ensure that DMR document and document center processes are followed in accordance with corporate document procedures and GMP.
* You will identify and implement document center process improvement projects.
* Provide back up to all team members through maintaining a working knowledge of all jobs in the department.
* You will assist with special projects as assigned by Team Supervisor.

What you need

* BS or BA degree (Engineering, Business, Computer Technology preferred) or equivalent of relevant experience.
* 3+ years of experience
* Knowledge of drafting and engineering practices and configuration management processes and practices
* Knowledge of industry regulatory practices and procedures