Description: 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.
Lead others on this project and perform the hands on work as well.
Assessment of current GMP work instructions and creating a subsequent plan to optimize SOP content while ensuring clear, concise instructions for production operations.
Lead Sterile Product Manufacturing SOP Optimization project and provide technical writing, SOP generation and update, as well as the creation of an OJT skills assessment.
Manage SOP Optimization Project: Project to include assessment of current GMP work instructions and subsequent plan to optimize SOP content while ensuring clear, concise instructions for production operations.
Will also provide Technical writing support for aseptic operations, to include technical writing to include drafting new/revised SOPs, forms, training materials, and OJT skill assessment documents.
Position will report to training department and interact with managers, supervisors, and technicians.
W2 ONLY!! NO CORP TO CORP!!
Must have bachelor's degree.
Technical Skills to provide project support.
Must have experience with managing an SOP Optimization Project.
Hands on tactical work is more important than management skills.
Knowledge of Quality Systems, specifically pertaining to Quality Assurance and Quality Control.
Understanding of aseptic and packaging/inspection operations.
Project Management skills.
Flexibility to respond to constantly changing conditions and priorities.
Ability to make sound and effective decisions under pressure.
Demonstrate critical thinking and proficiency in risk management.
Experience w/ Aseptic Techniques, Manufacturing, GMP and FDA.
Having set up a new, full-lifecycle PMO, cGMP experience and previous work history in a regulated environment is a HUGE plus.
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Job ID: 17-02118
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