Documentation Specialist I
Saint Joseph, MO
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
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.
- 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- Issuance of revised documents including archival of superseded documents.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.
documentation. Assist with archiving.
- 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 BIVI's excellent reputation in the
knowledge of production workflows.
- Minimum of high school degree or GED and two (2) years' experience in biological production environment or similar
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