Documentation Technician - JobsRUs.com : Job Details

JobsRUs.com

is seeking to hire a Documentation Technician for our client in Austin TX!

Benefits Available!

Weekly Pay!

$21.50/Hour

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 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 cGMPs, SOPs 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 Associates 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.