Job Title: Documentation Technician
Job Location: Austin ,TX
Job Duration: 12 Months+
Job Description:
This position supports the operational activities of the site through tasks associated with creation and maintenance of quality documentation.
These activities are based on written procedural requirements set up both locally and at higher corporate authority.
Create, coordinate, implement and archive Plant Change Control documentation, Standard Operating Procedures (SOP's), Batch Records (Work Orders), etc.
Maintain critical quality documentation related to Change Control, Validation system, including Installation Qualification and Operational Validations, and Engineering Change Requests.
Coordinate and implement all policies, procedures, and specifications received from Corporate that apply to the Austin Plant.
Responsibilities:
Review and coordinate the creation, edit, and routing of new and revised Standard Operating Procedures and Batch Records as requested for the Austin and Round Rock manufacturing sites.
Maintain Master Batch Record history files.
Create and issue Batch Record packages, using the Document Management System (DMS), to all proper operational areas within the Austin and Round Rock manufacturing sites, based on the plant manufacturing schedule.
Maintain the documentation library including the issue, receipt and tracking of validation packages, batch records, logbooks, etc.
maintained in the Documentation Storage Room.
Perform administrative review of validation packages to ensure compliance with local SOPs.
Perform administrative review of change control requests and track linkage to the documentation and validation changes.
Adhere to camps, SOP? s and plant policies / procedures.
Actively takes part in problem solving tasks that involve interaction with all plant disciplines.
Ensures the prompt creation and delivery of proper documents.
Implement approved documents within the plant document management system.
Responsible for coordinating the logbook management process.
Responsible for the receipt, review and distribution of all new and revised corporate policies, procedures, and specifications.
Coordinate the biennial review process for controlled documents.
Coordinates records management activities related to local and off-site storage of documents.
Once set up, may act as a Qualified Fellow Employee (QFE) or cross-train other individuals in their area of focus.