Technical Document Specialist II - Sr. Technical Document Specialist at Grifols

Technical Document Specialist II - Sr. Technical Document Specialist

Location: NC-Clayton, US Contract Type: Regular Full-Time Area: MANUFACTURING

Technical Document Specialist II

The Technical Document Specialist is responsible for using technical knowledge/concepts while partnering with manufacturing teams to create and revise paper and electronic manufacturing documents including BPRs, SOPs, CCRs, Manufacturing Methods, Investigation reports, etc. Will ensure documents are streamlined, align with the manufacturing processes and procedures and that they comply with regulatory standards. The Technical Document Specialist II is also responsible for using technical knowledge/concepts teams to perform discrepancy investigations, develop corrective/preventive actions.

Primary responsibilities for role:

• Write new procedures (i.e. paper and electronic batch production records, standard operating procedures, etc.) regarding manufacturing process.
• Consult with technicians to ensure ease of read and understanding of documents, procedures, etc.
• Collaborate with trainers to ensure clarity in regards to document revision training.
• Facilitate training on document revisions and track documents.
• Ensure correct revisions and documents are available when needed while also tracking all documents and their workflow.
• Provide assistance in locating requested documents needed for investigations and may serve as a subject matter expert (SME) during investigations.
• Maintain new logbooks each year by reviewing to ensure documents are signed off and complete.
• Review documents during audit and store in archives was complete. May be sought for counsel within field of expertise.
• Complete SAP related activities related to investigations and CAPAs. Programming (math.js, Java, PASX, etc.) experience strongly preferred.

Sr. Technical Document Specialist

The Sr. Technical Document Specialist is responsible for using technical knowledge/concepts while partnering with manufacturing teams to perform manufacturing investigations for associated quality notifications and create and revise paper and electronic manufacturing documents including BPRs, SOPs, CCRs, Manufacturing Methods, etc. Will ensure documentations are streamlined, align with the manufacturing processes and procedures and that they comply with regulatory standards. Lead projects of larger scope (or portions of projects) and is often called upon by peers for guidance. May direct a small group of employees' work/activities.

Primary responsibilities for role:

• Must be able to perform all responsibilities described in the Technical Document Specialist job description.
• Must be able to perform complex manufacturing investigations, and drive closure of corrective/preventive actions.
• May direct a small group of employees' work/activities.
• Manage Change Control Process.
• SME for processing equipment & workflow for documentation for Manufacturing (i.e. BP Rs)
• SME for documentation related systems (DCM, Runbooks, SAP QM, etc.)
• Serves as a consultant to management within a specified area/discipline (i.e. documentation, incidents, CAPS, training and environmental monitoring.)
• Programming (math.js, Java, PASX, etc.) experience strongly preferred.

Education

Technical Document Specialist II BS/BA degree and 2 years of related experience. An equivalent combination of education and experience may be considered.

Sr. Technical Document Specialist BS/BA degree and 5 years of related experience. An equivalent combination of education and experience may be considered.