Documentation Specialist
3 weeks ago
This role supports the operational activities of the site through tasks associated with creation and maintenance of quality documentation. The position is responsible for creating, coordinating, implementing, and archiving Plant Change Orders, Standard Operating Procedures (SOPs), Batch Records (Work Orders), etc. Additionally, the individual will maintain critical quality documentation related to Change Control, Validation system, including Installation Qualification and Operational Validations, and Engineering Change Requests.
Key Responsibilities- Review and coordinate the creation, edit, and routing of change orders for new and revised Standard Operating Procedures, Work Instructions, Batch Records, etc.
- 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.
- Maintain the documentation library including the issue, receipt and tracking of validation packages, batch records, logbooks, etc.
- Perform administrative review of validation packages to ensure compliance with local SOPs.
- Communicate with change initiators to ensure item content and the contents of the change package are correct and accurate.
- Perform administrative review of change control requests and track linkage to the documentation and validation changes.
- Adhere to cGMP's, SOPs and plant policies / procedures.
- Actively participates in problem solving tasks that involve interaction with all plant disciplines.
- Ensure the timely creation and delivery of appropriate documents including schedule change requests and manufacturing, laboratory, and manufacturing quality work order requests.
- Implement approved change orders / 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.
- 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.
- Must be able to think critically and analyze information objectively.
- Demonstrated teams participation with leadership behaviors preferred.
- Must be at least 18 years of age.
- Associates degree from an accredited college or university is required.
- 1 year of applicable experience is required.
- In lieu of the Associates degree requirement above, a High School Diploma with 3 or more years of experience in a quality or production related role in a GMP environment is required.
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