Documentation Specialist I

Location Saint Joseph
Salary from USD 12 / hour


Documentation Specialist I

Saint Joseph, MO


1 Year




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.

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- Issuance of revised documents including archival of superseded documents.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


- 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




  • Experience must be inclusive of documentation systems and Quality assurance requirements.
  • Strong computer skills to include Microsoft suite, IDEA for CON, Trackwise / GoTrack and organizational skills.
  • Proficient in SAP.
  • Excellent attention to detail, communication and written skill sets.
  • Ability to draft portions of technical documents and strong proofreading skills.
  • Must have experience with IDEA for CON, Trackwise/GoTrack, SAP (or similar business programs/software) and

knowledge of production workflows.


- Minimum of high school degree or GED and two (2) years' experience in biological production environment or similar



Location(s) St Joseph, MO, USA
Payment from USD 12 / hour, USD 27k / year
Job Type Full-Time, Permanent
Job Starts Immediately
Job Status Expired
Job ID #517459
Company CorTech LLC

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