VIVA USA Inc Technical Writer III in Marlborough, Massachusetts
Req Ref No: SRMATW10 Location: Marlborough, MA Duration: 3.0 months
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 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.
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.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.