Technical Writer

We are currently looking for a cGMP Technical Writer who will be responsible for writing, reviewing and driving production and quality documentation to approval.
• The Technical Document Writer will be responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals.
• Additional responsibilities might include tracking of the daily, weekly and monthly forecasted documentation priorities required to meet output quotas.
Key responsibilities/essential functions:
• Originate, revise and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records.
• Compile and draft procedural documentation using standard electronic publishing tools.
• Create and maintain templates for cGMP documents.
• Collaborate with individuals from various internal functional areas to generate and review new equipment, processing, set-up and operational documents within agreed upon timelines.
• Interview subject matter experts to obtain details in order to accurately capture content material.
• Demonstrate effective written and verbal communication skills.
• Monitor the flow of production documents and adjust workload and resources in an appropriate, organized and efficient manner.
• Work with cross-functional teams on the implementation of process improvement initiatives to increase quality in cGMP documentation.
• Demonstrate an ability to multi-task and manage multiple projects independently
• Maintain a safe work environment for self and staff.

• 3+ years of previous technical writing experience in a cGMP pharmaceutical environment.
• Experience in manufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements.
• Prior experience working in a biotech/pharmaceutical company.
• Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills.
• Proven ability to communicate complex ideas in a clear, concise manner.
• Working knowledge of MS Office Suite and an Electronic Document Management System (EDMS).
• Experience with Document Proficiency in Microsoft Office Products.

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (650)-399-0891

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