Quality Systems Specialist II - eQMS Team
Provides program management, technical and compliance support for electronic Quality Management Systems.
We are also open to candidates in the Foster City area or remote.
Responsibilities:
- Facilitate cross-functional meetings with internal and external parties as required
- Change control team meetings
- Business lead and stakeholder meetings
- Supports intake, triage and management of system enhancement request with stakeholders and business leads
- GNET (webpage) management
- Prepares presentations, communications & release notes summaries
- Tracking and monitoring deliverables associated with business and quality initiatives
- Interfaces with Business Process Leads and stakeholders for projects and system inquires
- Manage training curricula requirements and user adherence required for access to QMS systems
- Develop and produce reports to provide oversight, program support, impact assessments and remediations as needed.
- Supports issue management and investigations into business issues
- Execute assessments for workflow, business process, periodic reviews, training, deviations
- Supports CAPA implementation as needed
- 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
- Creates and maintains training materials in multiple formats
- Participates in developing system related SOPs, Work Instructions, and Business-Enabling Documents to align with compliance and business process requirements
- 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
- Assist compliance audits as required
- Prior experience with Quality Management Systems including Incident Management, Learning Management and Document Management Systems
- Proficiency in MS applications and data management
Required Education and Experience:
- 4 + years of relevant experience in a GMP environment related field and a BS.
- 2 + years of relevant experience and a MS