Function: Manufacturing Job Family: Bridge Manufacturing Services Band: PB
The Senior Technical Writer is responsible for writing, reviewing and driving production and quality documentation to approval in a cGMP Biopharmaceutical environment. The candidate must be able to prioritize and complete multiple tasks and follow through with documentation team members to achieve group and individual project goals.
• The Technical Document Writer will be responsible for producing high-quality cGMP technical production documentation.
• Must have experience in biotech cGMP manufacturing in the pharmaceutical industry.
• Additional responsibilities will include tracking daily, weekly and monthly forecasted documentation priorities required to meet output quotas.
Key responsibilities/essential functions:
• Originate, revise and maintain Standard Operating Procedures (SOPs), Manufacturing Production Records (MPRs) and Solution Preparation Records.
• Critically review documents for consistency and quality
• 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.
Quality Specific Goals:
• Aware of and comply with the GEHC 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 GEHC training requirements.
• Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 5 years technical writing experience in the Pharmaceutical Industry, or relevant Regulatory environment.
• Experience working in a biotech/pharmaceutical company under cGMP guidelines and possess a strong knowledge of cGMP requirements.
• Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills.
• Proven ability to communicate complex ideas in a clear, concise manner.
• Ability to engage and influence a range of personnel, peers, and superiors with a collaborative style
• Ability to communicate expectations and hold team accountable to all production and quality requirements.
• Experience with Trackwise, Electronic Document Management Systems (EDMS) or other electronic tracking software.
• Proficient in use of Windows environment software with advanced skills in Microsoft Word.
• Cell Culture experience.
• Protein Purification experience.
• Biological Technical Transfer experience.