Manufacturing Technical Writer
4 weeks ago
Overview:
· We need someone with Biologics Manufacturing experience who is familiar with cell culture processing. Experience with Electronic Batch Records (like PAS|X) is a plus.
· Responsible for creating technical instruction documents including standard operating procedures (SOPs), explaining complex information in a clear and concise manner and working with manufacturing experts to ensure accuracy of process descriptions.
· Support the overall GMP upstream and downstream manufacturing process, through the application of broad technical writing experiences, developing standard operating procedures for manufacturing processes as well as routine tasks in the production of bulk biologics therapies.
Must Haves:
· Experience in Biotechnology/Pharmaceutical Manufacturing: This is a Manufacturing Technical Writer; they need to have previous experience in Manufacturing of Pharmaceuticals (Biotech is preferred)
· Excellent Written and Verbal Communication Skills: Clear and effective communication including writing Batch records (paper or electronic) and SOPs.
· Strong Attention to Detail: Given the critical nature of the documents and processes involved, attention to detail is crucial to ensure accuracy and compliance.
· Manufacturing experience either working as Manufacturing Technicians or Manufacturing Associates with direct hands-on experience in manufacturing.
Duties:
· Generates/revises manufacturing batch records, both in the electronic batch record system (Client-X) and the document management system
· Generates/revises standard operating procedures and other related documents in clear and easy to understand language
· May assist with management of change controls in the Quality Management System
· Technical Writing Support of Upstream, Downstream and Central Services
· Manage updates and revisions to technical process documentation
· Interfaces across multiple departments with subject matter experts for review and approval of documentation and changes
Education:
· Bachelor’s degree is preferred in a Science discipline (chemistry, biology, engineering, pharmacy) or experience in Life Sciences technical writing preferred.
Pay Range: $40 - $50/Hou
Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
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Browse our website below for additional information on our company.\r
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The Fountain Group\r
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4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
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