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Quality Engineering Data Analyst

Technical Writer

Job in Northborough, Worcester County, Massachusetts, 01532, USA
Listing for: Artech Information System LLC
Full Time position
Listed on 2025-12-22
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Data Analyst
Job Description & How to Apply Below
Position: Technical Writer I (5625794)

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description
  • Ensure timely and efficient creation/review of Label & Pack documents: standard operating procedures, batch records, technical protocols and reports, etc.
  • Contribute understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (CGMP), analytical skills, and interpretation of the information to be captured on the document.
  • Ensure a consistent style of presentation of Label and Pack documents to maintain quality and ease of review.
  • Coordinate with Engineering on tasks for validation qualification, preventative maintenance and re-qualification program processes.
  • Act as subject matter expert (SME) for documentation with Development and Training (D&T), and provide input in cross-functional teams, including during Quality Assurance (QA) and Quality Control (QC).
  • Help develop OJT's for proficiency of L&P staff with respect to process knowledge and critical parameters; ensure understanding and interpretation of results from tools deployed in the process.
  • Support readiness for regulatory inspections and compliance audits.
  • Assess current documentations for Error Reduction updates and ensure timely revision and review of periodic review.
  • Support development of junior analysts through mentoring.
  • Coordinate CAPA tasks with document changes for timely closure of compliance events with deviations investigators.
  • Revise standard operating procedures as needed.
  • Practice safe work habits and adhere to Sanofi's safety procedures and guidelines.
    • Skills
  • Minimum of 5 years of experience in a regulated environment.
  • Previous experience with technical writing for manufacturing in a regulated environment.
  • Use of documentation controls systems to manage workflow.
    • Qualifications

    Education:

    Bachelor's degree in a related discipline.

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