Senior Manufacturing Documentation Specialist

Jobtailor; Clayton (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Jobtailor is seeking a documentation specialist to partner with manufacturing teams to write and revise paper and electronic manufacturing documents and procedures. The role emphasizes alignment with processes, regulatory compliance, and clear readability for technicians.

You'll train staff on document revisions, track workflows, and act as SME during investigations, maintaining logbooks and archival storage.

Qualifications

• BS/BA degree and 2 years of related experience.
• Equivalent combination of education and experience may be considered.
• Technical knowledge applicable to manufacturing documentation.
• Ability to create and revise paper and electronic manufacturing documents (BPRs, SOPs, CCRs, Manufacturing Methods, investigation reports).
• Ensure documents align with manufacturing processes and regulatory standards.
• Ability to perform discrepancy investigations and develop corrective/preventive actions.
• Ability to write manufacturing procedures and batch production records.
• Consult with technicians on document readability and understanding.
• Collaborate with trainers on document revision training.
• Facilitate training and track document revisions/workflows.
• Location for investigations and serve as SME.
• Maintain logbooks and conduct audits archives.
• SAP-related activities for investigations and CAPAs.
• Programming experience with Math.js, Java, PASX strongly preferred.

Responsibilities

• 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 compliant with regulatory standards.
• Consult with technicians to ensure documents 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 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.

Skills

Manufacturing Documentation

SOP Creation

Batch Records (BPRs)

Discrepancy Investigations

Regulatory Compliance

Documentation Review

Training Facilitation

Readability Consultation

Document Revision

Education

BS/BA degree or equivalent in related field

Tools

SAP

Math.js

Java

PASX

Job description

Jobtailor is seeking a documentation specialist to partner with manufacturing teams to write and revise paper and electronic manufacturing documents and procedures. The role emphasizes alignment with processes, regulatory compliance, and clear readability for technicians.

You'll train staff on document revisions, track workflows, and act as SME during investigations, maintaining logbooks and archival storage.