GMP Documentation Specialist II

Unicon Pharma Inc; Austin (TX); On-site; USD 52,000 - 68,000; Full time

Job summary

Unicon Pharma Inc. seeks a detail-oriented Documentation Technician II to support GMP manufacturing operations by creating, maintaining, implementing, and archiving quality documentation.

The role handles Change Orders, SOPs, Batch Records, Work Instructions, and validation packages, coordinating with manufacturing, quality, lab, and engineering to ensure accurate, compliant documentation and proper routing.

Qualifications

• Associate degree or equivalent in a related field.
• 1 year of GMP-related experience.
• 3+ years GMP with HS Diploma.

Responsibilities

• Create, edit, coordinate, route, implement, and archive Change Orders, SOPs, Work Instructions, Batch Records, and related documentation.
• Create and issue Batch Record packages through the Document Management System (DMS).
• Maintain the documentation library, including validation packages, batch records, logbooks, and controlled records.
• Perform administrative reviews of validation packages and change orders for compliance with local SOPs.
• Review change control requests and track associated documentation and validation changes.
• Communicate with change initiators to ensure documentation packages are complete and accurate.
• Implement approved documents and change orders within the plant document management system.
• Coordinate logbook management activities.
• Receive, review, and distribute new and revised corporate policies, procedures, and specifications.
• Coordinate the biennial review process for controlled documents.
• Coordinate local and off-site records management and document storage activities.
• Assist with writing and revising Standard Operating Procedures.
• Ensure timely creation and delivery of manufacturing, laboratory, quality, and schedule-related documentation.
• Follow all cGMP requirements, SOPs, and plant policies/procedures.
• Participate in process improvement and problem-solving activities.
• Support cross-training and knowledge-sharing activities as needed.
• Perform other related duties as assigned.

Skills

Document control

MS Office

English communication

Attention to detail

Multi-tasking

Analytical thinking

Cross-functional teamwork

Education

Associate degree

High School Diploma + 3+ years GMP

Tools

Microsoft Word

Microsoft Excel

Outlook

Database applications

Job description

Unicon Pharma Inc. seeks a detail-oriented Documentation Technician II to support GMP manufacturing operations by creating, maintaining, implementing, and archiving quality documentation.

The role handles Change Orders, SOPs, Batch Records, Work Instructions, and validation packages, coordinating with manufacturing, quality, lab, and engineering to ensure accurate, compliant documentation and proper routing.