Process Writer/Technical Writer with CSV.

Cardinal Integrated

Boston, MA

JOB DETAILS
SKILLS
Best Practices, Biotech and Pharmaceutical, Communication Skills, Documentation, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Healthcare, Java Decompiler (JAD), Laboratory Automation, Network Administration/Management, Operations Processes, Organizational Skills, Standard Operating Procedures (SOP), Standards Development, System Validation, Technical Writing, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Boston, MA
POSTED
Today
Process Writer/Technical Writer with CSV

Client is looking for a process writer with experience in CSV and writing SOPs (Standard Operating Procedures) for Healthcare clients. Should have experience in GMP process documentation and creating Best Practices standards, must be able to coordinate with multiple stakeholders and vendors, setup JAD sessions, document requirements. ISO experience/certification is a plus. Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments. Project deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. 4- 6 years of work experience. Experience/exposure to Computerized System Validation (CSV) Good communication and technical writing skills are a must.

About the Company

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Cardinal Integrated