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cGMP Technical Writer / Technical Document Writer--Pharma

Location: Marlborough, MA
Date Posted: 05-08-2018
TECHNICAL DOCUMENT WRITER- BIOMANUFACTURING 

The schedule for this position is Monday – Friday, 8:00am – 4:30pm. 
only submit folks with the below exp: 
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. 




JOB TYPE: TECHNICAL DOCUMENT WRITER- BIOMANUFACTURING 
Function: Manufacturing Job Family: Bridge Manufacturing Services Band: Other Salary 

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 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. 
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 Microsoft Office Products. 
Preferred Qualifications: 
• Associates degree in a scientific discipline or equivalent experience. 
• Cell Culture experience. 
• Protein Purification experience. 
• Biological Technical Transfer experience.
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