Technical Writer I (5625794)
Artech Information System LLC, Northborough, MA, United States
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 guideline
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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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 guideline
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
#J-18808-Ljbffr