Job Description

This position has responsibility for key documentation within the assigned area including but not limited to the coordination of documentation systems to ensure compliance, control, accountability, traceability, communication, retrieval and archiving of critical documentation throughout the lifecycle of the documents. This includes creation, routing, and issuance.

This position will also ensure that all documents are appropriately filed and indexed to provide accessibility as necessary, creation of training through LOS, maintenance of data stores of various documentation functions (document status, archived documents), and to provide timely customer service to all departments. Performs final document review for accuracy and completeness.

Duties & Responsibilities:

- Initiate and support workflows in Trackwise (or related) upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards, Special Outlines, Batch Records).

- Issuance of revised documents including archival of superseded documents. Initiate Biennial review workflows for controlled document types (SOPs, forms, quality standards).

- Write, review and update SOPs/forms within IDEA for CON as necessary. Schedule and facilitate cross-functional meetings for periodic reviews of OOPs and Special Outlines.

- Maintain component data stores and make appropriate assignments.

- Performs inventory analysis and adjustments within the SAP database.

- Assist as necessary to maintain systems for equipment log books generation, form maintenance, and other production documentation. Assist with archiving.

- Collects and Trends data as necessary

- Customer service functions include assisting with Change Control workflows. Provides expertise with IDEA for CON workflows.

- Performs all Company business in accordance with all regulations (e.g. EU, APHIS, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain client's excellent reputation in the community.