Technical Document Writer

Job Description

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