Regulated Manufacturing Technical Writer & SME

Artech Information System LLC; Northborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A prominent IT staffing company in Massachusetts is seeking an experienced documentation specialist to ensure the efficient creation and review of Label & Pack documents. The successful candidate will have at least 5 years of experience in a regulated environment and a background in technical writing. Responsibilities include coordination with engineering teams, regulatory compliance support, and mentoring junior analysts. This role is essential for maintaining documentation quality and adherence to safety protocols.

Qualifications

• Minimum of 5 years of experience in a regulated environment.
• Previous experience with technical writing for manufacturing in a regulated environment.
• Use documentation controls systems to manage workflow.

Responsibilities

• Ensure timely and efficient creation/review of Label & Pack documents.
• Contribute understanding of Good Documentation Practices and Current Good Manufacturing Practices.
• Ensure a consistent style of presentation of Label and Pack documents.
• Coordinate with Engineering on tasks for validation qualification.
• Act as subject matter expert for documentation.
• Help develop OJTs for proficiency of L&P staff.
• Support readiness for regulatory inspections and compliance audits.
• Assess current documentations for Error Reduction updates.
• Support development of junior analysts through mentoring.
• Coordinate CAPA tasks with document changes.
• Revise standard operating procedures as needed.

Skills

Technical writing for manufacturing

Experience in a regulated environment

Use of documentation control systems

Education

Bachelor's degree in a related discipline

Job description

A prominent IT staffing company in Massachusetts is seeking an experienced documentation specialist to ensure the efficient creation and review of Label & Pack documents. The successful candidate will have at least 5 years of experience in a regulated environment and a background in technical writing. Responsibilities include coordination with engineering teams, regulatory compliance support, and mentoring junior analysts. This role is essential for maintaining documentation quality and adherence to safety protocols.