Technical Writer I - 1 year contract (renewable)
• Write and revise manufacturing documents, including but not limited to Master Batch Records, Quality Control Sheets, product labels, Material Specifications, and Standard Operating Procedures.
• Serve as primary advisor for documentation to Cell and Gene Therapy Clients.
• Implement EPS (Error Prevention System) to batch record templates.
• Partner with MSAT scientists and Manufacturing staff to develop user-friendly batch record templates.
• Offer suggestions on improving document format to make documents more usable to the target audience.
• Provide assistance and advice to internal customers on the use of the Electronic Document Management System.
• Other document projects as assigned by the department manager.
• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
• Experience writing manufacturing/analytical documentation, Standard Operating Procedures, and Process Validation Protocols in a cGMP setting preferred.
• Cell culture, molecular biology or biotech/biopharma laboratory and/or manufacturing experience, preferably in a cGMP-manufacturing environment
• Technical writing including manufacturing documentation and Standard Operating Procedures
• GMP compliance knowledge; direct knowledge of relevant documentation requirements for cooperative manufacturing
• Part 11 compliance knowledge
• Computer software skills including Microsoft Office, database and spreadsheet creation and maintenance, filing, organization, record keeping and planning skills, multiple projects, time management
• Excellent Written and oral communication skills; listening skills; independent and self-directed
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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