Cell Therapies Documentation Specialist
Kalleid is looking for a Cell Therapies Documentation Specialist to join our team!
Kalleid, Inc., is a boutique laboratory IT consulting firm that has served the scientific community since 2014. We work across the value chain in R&D, clinical and quality areas to deliver support services for software implementations in highly complex, multi-site organizations.
We are actively seeking a Cell Therapies Documentation Specialist who will support the successful implementation of an environmental monitoring system in a Cell Therapies Manufacturing Facility for a global biotechnology company.
Job Title: Cell Therapies Documentation Specialist
Location: Cambridge, MA
Duration: 3–6 months
Standard Working Hours: 40+ hours/week
Position Summary
The Cell Therapies Documentation Specialist will work with subject matter experts (SMEs) and the vendor to develop required documentation for an environmental monitoring system in a Cell Therapies Manufacturing Facility. Deliverables include a usage SOP, a Documentation Plan, along with several supporting documents.
Primary Job Duties and Responsibilities:
- Coordinate the demands of the client while ensuring content is complete and meets regulatory requirements
- Work with SMEs and vendor to ensure that the required documentation is complete, clear, and accurate
- Gain sufficient expertise on laboratory systems to critically evaluate content
- Manage multiple writing projects
- Drive document coordination and document release
- Manage change requests
- Ensure consistency across documentation through approved templates and corporate style
- Facilitate content reuse
Required Skills/Attributes:
- Must be good at working with people and be a good listener
- Must be a good team player, be motivated to meet commitments, be accountable to achieve goals and targets while maintaining professional relationships
- Must possess good interpersonal and strong written/verbal communication skills
- Must have well developed skills in prioritizing, multitasking, organization, and time management
- Must be highly motivated and detail oriented with good organizational skills
- Must have the ability to work in a dynamic, fast paced environment with shifting priorities
- Must have strong working knowledge of cGxP/GMP compliance and guidance provided by FDA
- Must have a scientific background with the ability to understand complex technical material
- Strong facility with Microsoft® Word® application
Preferred Education/Experience:
- Batchelor’s degree in biology or related field
- 2–5 years of experience developing cGxP-compliant documentation
- Familiarity with quality management systems a plus
