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GMP Technical Writer

Location: Marlborough, MA
Date Posted: 01-10-2019

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.
Required Qualifications:
•             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.
Preferred Qualifications:
•             Cell Culture experience.
•             Protein Purification experience.
•             Biological Technical Transfer experience.
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