Process / QMS Analyst (REMOTE- EST)

Overview

Remote
Depends on Experience
Contract - W2
Contract - 6 Month(s)
No Travel Required

Skills

r&D
Business Process Management
Medical Safety

Job Details

Please note that this is a 6+ months contract position.

Qualifications

  • Position is remote; manager is open to various time zones but may prioritize EST

  • Role is in the R&D Quality department

  • Candidates with 5+ years of experience preferred

  • Bachelor s degree highly preferred; Associate's degree with relevant experience will be considered

  • Title of the role: Business Process Management

  • Must be highly involved in business process management within the Medical Safety area

  • Experience in creating or revising SOPs, managing end-to-end processes

  • Experience in deploying compliance training

  • Experience deploying in Quality Management Systems (QMS)

  • Experience with TrueVault

  • Experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS)

  • Must have excellent problem-solving skills

  • Strong written and verbal communication skills

  • Highly detail-oriented and organized

  • Ability to multi-task and manage high-volume projects

  • Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint)

  • Should have Google Cloud Platform (Good Clinical Practice) experience

Job Description

This position reports into Process and Data Management (PDM) within R&D Quality. The Process and Personnel Qualification Management Expert (PPQME) is responsible for supporting Medical Safety/PV business process owners in the end-to-end process for procedural document development and compliance training development and deployment in the Quality Management System (QMS) framework.

Responsibilities:

  1. Define and manage project plans, tasks, schedules, scope, timelines, and deliverables

  2. Perform project management across the lifecycle from procedural document development and approval (in EDMS) to training identification, target audience identification, training material development, and training deployment (in LMS)

  3. Maintain ongoing communication with business owners on project progress and resolution of issues

  4. Work with peers in PDM to ensure compliant training and procedural documents are installed for dedicated processes

Applicants must provide their phone number. Reference job number is A4870

 

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