Pay $40-$50 per hr.
This is a hybrid position with onsite days as Tuesday, Wednesday and Thursday (We are looking for local candidates only)
Required Skills :
2-3 years experience in biotech or another regulated industry
Microsoft Suite (Word, Excel & PowerPoint)
Veeva or ComplianceWire administration (highly desired)
The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs.
Position details :
- Assist in governance of Quality System applications, including harmonization of processes across sites
- Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting / workshops with Site Process Owners and business SMEs
- Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues
- Follow-up on requests, issues, and projects and report statuses to manager / working teams
- Initiate and manage change controls, with associated documentation requirements, to completion
- Ensure system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations / CAPAs associated with Quality Systems
- Support investigation, escalation, and resolution of issues identified on the system
- Support validation activities as requested; this includes but is not limited requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports
- Support manager with ongoing communication from vendor / IT where required
- Provide customer support through system and training management and onboarding of new users
- Generate metrics to support quality systems
- Support regular system updates / releases and provide assessment of and recommendations regarding new features
- Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created and / or modified
ACADEMIC / TECHNICAL QUALIFICATIONS :
- Bachelor’s degree or higher in relevant computer / technical / quality / scientific discipline, preferably multi-disciplinary with a strong technical and quality background
- Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility
- Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.
- Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements
- Knowledge of Regulatory Compliance and ICH Guidelines
Clinical Systems/EHR Quality Data Specialist
Extract data from various sources, including electronic health records (EHRs), claims databases, registries, and other clinical systems and develop the data pipeline and architecture to efficiently use the data for quality metrics. This position is responsible for working with the care team to suppo...
Quality Systems Specialist
Ensure the system is maintained in a validated state by participating in periodic user access reviews, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems. Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, p...
Quality Systems Training and Documentation Specialist 2049373
Quality Systems Training and Documentation Specialist 2049373. As a Quality Systems Training and Documentation Specialist, you'll manage daily operations, training content via LMS, and documentation through EDMS across all GxP areas. Skilled in LMS and EDMS, preferably ComplianceWire and Veeva Quali...
Quality Systems Specialist
The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. Ensure system is maintained in a validated state b...
Quality Systems Specialist 2
At MilliporeSigma, in our Norwood OH site, as the Quality Systems Specialist 2, you are a key contributing team member of the Quality Assurance team behind the site’s alignment to the ISO 9001:2015 Quality Management System (QMS) standard, as well as Merck Corporate and Life Science Divisional Quali...
Quality Systems Specialist
As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with Client policies, QMS standards, and local regulations. The primary focus of this role will be to support management of Qu...
Quality Systems Specialist
The Senior Specialist of Quality Systems and Compliance focuses on improving and maintaining quality management systems, ensuring compliance, and supporting audit and inspection readiness. Quality Systems Specialist 2051218. Lead quality compliance education, foster a quality-focused culture, and ca...
Clinical Systems/EHR Quality Data Specialist
Extract data from various sources, including electronic health records (EHRs), claims databases, registries, and other clinical systems and develop the data pipeline and architecture to efficiently use the data for quality metrics. This position is responsible for working with the care team to suppo...
Quality Specialist, GxP Vendor Quality and Audit Management
Quality Specialist, GxP Vendor Quality and Audit Management 2051104. Quality Specialist Audit Management improves the Veeva system through testing, report development, and vendor management. Familiar with CAPA and electronic systems like especially Veeva. ...
Quality Systems Training and Documentation Specialist
Quality Systems Training and Documentation Specialist 2049373. As a Quality Systems Training and Documentation Specialist, youll manage daily operations, training content via LMS, and documentation through EDMS across all GxP areas. Skilled in LMS and EDMS, preferably ComplianceWire and Veeva Qualit...