Document Control Technician

Documentation Technician II

We are seeking a detail-oriented Documentation Technician II to support quality and manufacturing operations at our Austin facility. This role will manage and maintain controlled documentation, including SOPs, Work Instructions, Batch Records, Change Controls, and Validation documents, while ensuring compliance with cGMP requirements and site procedures.

Key Responsibilities

• Create, review, route, issue, revise, and archive controlled quality and manufacturing documents.
• Coordinate SOPs, Work Instructions, Batch Records, Change Orders, and Validation documentation.
• Perform administrative reviews of documents and change controls for accuracy and compliance.
• Maintain document libraries, records, logbooks, and documentation tracking systems.
• Coordinate issuance and distribution of batch record packages based on manufacturing schedules.
• Support implementation of approved document and change control updates in the Document Management System.
• Coordinate periodic reviews of controlled documents and records management activities.
• Assist with SOP writing, process improvements, and cross-functional documentation activities.
• Ensure all documentation activities comply with cGMP, SOPs, and plant policies.

Qualifications

• Associate's degree with 1+ year of applicable experience, OR High School Diploma with 3+ years of quality/production experience in a GMP environment.
• Experience with document control, quality documentation, or manufacturing documentation preferred.
• GMP/cGMP experience strongly preferred.
• Familiarity with SOPs, batch records, change control, validation, or controlled documents.
• Strong attention to detail and organizational skills.
• Proficiency with Microsoft Word, Excel, Outlook, and standard computer systems.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Work Environment

Primarily an office-based, sedentary role within a manufacturing environment. Occasional lifting of up to 25 lbs. and less than 5% travel may be required.