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Documentation Technician

2 months ago

Austin, United States Compunnel Inc. Full time

Position Summary: 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 established 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 are applicable to the Austin Plant. Essential Duties & 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 appropriate operational areas within the Austin and Round Rock manufacturing sites, based on the plant manufacturing schedule (s). ? 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 cGMP?s, SOP?s and plant policies / procedures. ? Actively participates in problem solving tasks that involve interaction with all plant disciplines. Ensures the timely creation and delivery of appropriate 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 established, may act as a Qualified Fellow Employee (QFE) or cross-train other individuals in their area of focus. ? Perform other related duties as assigned or required. Knowledge, Skills & Qualifications: ? Demonstrated skills on a personal computer using word processing, spreadsheet, and/or database software as well as standard business communication tools such as Microsoft Outlook, etc. ? Must be able to prioritize and manage a high volume of complex activities; priorities may change rapidly and/or unexpectedly. ? Must have excellent written and verbal English communication skills. ? Must be detail oriented, and able to pay close attention during comparison of details in multi-page documents while addressing urgent customer needs that may result in interruptions. ? Demonstrated teams participation with leadership behaviors preferred. Education and Experience: ? Associates Degree, equivalent of 60 hours college credit, or relevant certification and 2 years of applicable experience In lieu of the Associate?s degree, etc requirement above, a high school diploma (or equivalent) with 4 or more years of experience in a quality or production related role in a GMP environment is required.