Job Details

  • Title: Quality Specialist
  • Code: RCI-08642
  • Location: Oceanside California (CA) 92056
  • Posted Date: 07/28/2020
  • Duration: 12 Months
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  Job Description

The contractor will start working in a support capacity, not managing programs themselves.

  • Governance Meeting Management
  • Enhancement Request Intake Management
  • Triaging enhancements with stakeholders
  • Webpage management
  • BPO/BPL Meeting Management
  • CCT Meeting Management
  • Communications & Release Notes Management
  • Tracking and monitoring deliverables associated with business and quality initiatives
  • Coordinate completion of deliverables with BPLs and Business Administrators
  • Interfaces with Business Process Leads and stakeholders for projects and system inquires
  • Manage Training Requirements/Adherence for Quality Management Systems
  • Develop and produce reports to monitor training and role assignment compliance; remediate findings as needed
  • Support Issue Management & Investigations into business issues
  • Execute assessments for workflow, business process, periodic reviews, training, deviations
  • Supports CAPA implementation as needed
  • Perform Business Analysis, Information Architecture
  • Supports Process Mapping, Audit Trail Review and UI testing tasks for the implementation and/or maintenance of Quality Management systems
  • Support documentation for the Quality Management systems as needed to comply with policy and procedures
  • Revise system related SOPs, Work Instructions, and Business-Enabling Documents to align with Quality documentation initiatives
  • Author and review Quality Records (Deviations, CAPAs, Change Controls); assist with investigations, assessments, and effectiveness checks to support Quality Management Systems
  • Support periodic reviews of validated computerized systems
  • Prior experience with Quality Management Systems including Incident Management, Learning Management and Document Management Systems
  • Required: 3-5 years Minimum industry experience in this type of role
  • Required: Minimum BS Degree (Prefer technical background)
  • Prefers a candidate with a background in Pharma, Compliance and Technology
  • Familiar with basic a Project Management software program (eg. Powerpoint, Excel)
  • Logical, self-motivated, fast learner, highly organized, good with people, and must have strong communication skills