VIVA USA Inc TECHNICAL DOCUMENT WRITER- BIOMANUFACTURING in Marlborough, Massachusetts
Req Ref No: SRMATW301 Location: Marlborough, MA Duration: 4.5 months
TECHNICAL DOCUMENT WRITER- BIOMANUFACTURING
We are looking for a Technical Document Writer to work with our expert Biomanufacturing team.
What you’ll do:
Responsible for writing, reviewing and driving production and quality documentation to approval. Responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals. Originate, revise and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records. Originate, track and close Quality documents (CAPA’s, CR’s, TCR’s, Deviations). 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. 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.Demonstrates ability to communicate with co-workers and leadership.
Preferred Qualifications :
Associates degree in a scientific discipline or equivalent experience. Cell Culture experience. Protein Purification experience. Biological Technical Transfer experience. Prior experience working in a cGMP biopharmaceutical manufacturing environment. Experience with single-use biomanufacturing systems
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.