Technical Document Specialist II

• Partner with manufacturing teams to create and revise paper and electronic manufacturing documents
• Write new procedures, including paper and electronic batch production records and standard operating procedures
• Ensure manufacturing documents are streamlined, aligned with processes and procedures, and compliant with regulatory standards
• Consult with technicians to ensure documents and procedures are easy to read and understand
• Collaborate with trainers to clarify document-revision training
• Facilitate training on document revisions and track documents
• Ensure correct revisions and documents are available when needed while tracking document workflows
• Assist in locating documents needed for investigations and serve as a subject matter expert during investigations
• Maintain annual logbooks and verify documents are signed off and complete
• Review documents during audits and ensure complete archival storage
• Provide counsel within the field of expertise
• Complete SAP-related activities for investigations and CAPAs

• BS/BA degree and 2 years of related experience
• An equivalent combination of education and experience may be considered
• Technical knowledge/concepts applicable to manufacturing documentation
• Ability to create and revise paper and electronic manufacturing documents, including BPRs, SOPs, CCRs, Manufacturing Methods, and investigation reports
• Ability to ensure documents align with manufacturing processes and procedures and comply with regulatory standards
• Ability to perform discrepancy investigations and develop corrective/preventive actions
• Ability to write manufacturing procedures and batch production records
• Ability to consult with technicians on document readability and understanding
• Ability to collaborate with trainers on document revision training
• Ability to facilitate training and track document revisions and workflows
• Ability to locate documents for investigations and serve as a subject matter expert
• Ability to maintain logbooks and review documents for completeness and audit archiving
• SAP-related activities for investigations and CAPAs
• Programming experience with math.js, Java, PASX, etc. strongly preferred

Demonstrates expertise in creating and revising manufacturing documents, ensuring compliance with regulatory standards, and facilitating training on document revisions. Proficient in SAP-related activities and capable of performing discrepancy investigations and developing corrective actions.

• Manufacturing Documentation
• Standard Operating Procedures (SOPs)
• Batch Production Records (BPRs)
• SAP Activities for Investigations
• Discrepancy Investigations

• Manufacturing Documentation Creation
• Document Revision
• Regulatory Compliance
• Corrective/Preventive Actions Development
• Technical Knowledge of Manufacturing Concepts

• Collaboration
• Consultation
• Training Facilitation
• Document Readability Consultation

• Manufacturing Processes
• Audit Review
• Document Archiving
• Logbook Maintenance
• Subject Matter Expert

• SAP
• Math.js
• Java
• PASX