Technical Writer/PM - OQSIE
St. Louis, MO 63146
About the Job
One mid-level and two senior Technical Writer/Project Manager to write, edit and manage multiple technical writing projects simultaneously. Will not manage people, just writing projects.
We need an experienced Project Manager who has managed and performed technical writing and training projects. The training background should include creating curriculum, revising SOP’s and other GMP documents that are governed by a document control system, such as Trackwise or eReview. This person will lead others on this project and perform the hands on work as well. Must have experience with managing an SOP Optimization Project such as this: This project will include assessment of current GMP work instructions and creating a subsequent plan to optimize SOP content while ensuring clear, concise instructions for production operations. Hands on tactical work is more important than management skills.
Manage Sterile Product Manufacturing NHSD Document Optimization Project. Work with SMEs and project team to develop, draft, route for approval, and implement improved instructional documents (SOPs, Forms, Batch Records, and OJTs) for NHSD production operations.
Scope; Activities, Tasks:
Qualifications:
Excellent project management and organizational skills including the ability to independently understand, follow, and implement complex instructions and follow assignments through to completion.
We need an experienced Project Manager who has managed and performed technical writing and training projects. The training background should include creating curriculum, revising SOP’s and other GMP documents that are governed by a document control system, such as Trackwise or eReview. This person will lead others on this project and perform the hands on work as well. Must have experience with managing an SOP Optimization Project such as this: This project will include assessment of current GMP work instructions and creating a subsequent plan to optimize SOP content while ensuring clear, concise instructions for production operations. Hands on tactical work is more important than management skills.
Manage Sterile Product Manufacturing NHSD Document Optimization Project. Work with SMEs and project team to develop, draft, route for approval, and implement improved instructional documents (SOPs, Forms, Batch Records, and OJTs) for NHSD production operations.
Scope; Activities, Tasks:
- Manage document development, review, approval, and implementation for the NHSD Document Optimization Project. Ensure project deliverables are completed per the project timeline.
- Review and analyze existing procedures for concurrence with correct department methods through direct observation of aseptic manufacturing processes and interviews with subject matter experts.
- Draft new and revised SOPs, Batch Records, Forms, and OJT skill assessment documents.
- Write standard operating procedures with appropriate details that are easily understood, readily usable for consistency in training, and conform to company policies and government regulations.
- Review the impact of the proposed changes with regard to other support documents.
- Interact with internal departments to develop new and revised documents. Directly interact with the sites' Manufacturing, Quality, Validation, Regulatory and EHS Departments to ensure document revisions are accurate, executable and comprehendible.
- Track and report document status.
Qualifications:
Excellent project management and organizational skills including the ability to independently understand, follow, and implement complex instructions and follow assignments through to completion.
- Knowledge of Quality Systems as it relates to GMP documentation requirements
- Strong technical writing ability with experience writing instructional documents.
- Understanding of aseptic and packaging/inspection operations
- Project management and organizational skills
- Excellent verbal and written communication skills
- Interpersonal and communication skills required to build and maintain working partnerships with all levels of the organization
- Strong technical writing ability.
- Intermediate to advanced computer skills that include MS Word, Visio, PowerPoint, and Excel.
Source : OQSIE
