Category: Scientific & Clinical
Title: Technical Writer
Location: Summit, NJ
Schedule: 8am to 5pm Mon – Fri.
- Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation deliverables.
- Responsible for routing document deliverables through the Document Management system.
- May assist with writing deviations, CAPAs, Change Controls.
- Facilitate periodic reviews of SOPs and provide subject matter expertise in documentation best practice
- Responsible for assisting and facilitating in requirement gathering, documenting efficient procedural solutions to varied and complex challenges.
- Attend and participate in meetings and discussions to define and capture procedures and procedural changes
- Capture meeting notes and tasks and ensure timely distribution.
- Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
- Follows up with team members and cross functional team members to encourage timely review and approval.
- Promotes and provides excellent customer service and support
- Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
- Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers
- AA / AS degree or acceptable combination of education and practical experience
- Minimum 3 years' experience as technical writer developing procedural documentation, interfacing with stakeholders to align different and potentially conflicting needs.
- Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint Visio and Outlook with extensive background in database systems. Innate ability to learn new software.
- Strong written and verbal communication skills. Highly proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors.
- Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- Familiarity with FDA and EU environments and associated compliance regulations
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.