Technical Document Specialist II - Sr. Technical Document Specialist

Primary Responsibilities

• 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.
• May be sought for counsel within field of expertise.
• Complete SAP related activities related to investigations and CAPAs.

Qualifications

• BS/BA degree and 2 years of related experience.
• Programming (math.js, Java, PASX, etc.) experience strongly preferred.

Requirements

• Strong technical knowledge/concepts.
• Partnership with manufacturing teams.
• Ensuring documents align with manufacturing processes and procedures.
• Ensuring compliance with regulatory standards.

Benefits

• Enhance the lives of millions of people.
• Global healthcare company with presence in over 110 countries and regions.

Pay

TBD

Schedule

N/A

Skills

• Technical Document Specialist II: BS/BA degree and 2 years of related experience.
• Programming (math.js, Java, PASX, etc.) experience strongly preferred.

About the Role

The Technical Document Specialist is responsible for creating and revising paper and electronic manufacturing documents while ensuring compliance with regulatory standards. The Sr. Technical Document Specialist leads projects of larger scope and serves as a consultant to management within specified areas.