We are looking for a Technical Document Writer to work with our expert Biomanufacturing team. Do you have a passion for Biotechnology? Then we would love to hear from you.
What you will 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 (CAPAs, CRs, TCRs, 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 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 / Who you are:
· 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.
· 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
Who we are?
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you will feel right at home here. If you are flexible, curious, and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.