cGMP Technical Writer

Description

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.

Quality Specific Goals

• Aware of and comply with the client Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Aware of and comply with Stop Order, Concessions, ESD ECO, Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices, as associated with this job type/position.

Training

Aware of and comply with client training requirements.

Qualifications

Required Qualifications

• 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 MS Office Products.

Preferred Qualifications

• Associates degree in a scientific discipline or equivalent experience.
• Cell Culture experience.
• Protein Purification experience.
• Biological Technical Transfer experience.

Additional Information

To know more about this position please contact after applying to the position on;

Ujjwal Mane ujwal.mane(at)collabera.com 973-805-7557