The Quality Analyst is primarily responsible for ensuring quality and compliance by providing support and guidance at an innovative clinical trials and financial services company.
The Quality Analyst will ensure that all documentation meets company, financial, and SSAE 16 standards. The Quality Analyst will interface with the development team and the Business Analysts to ensure that the Global Quality Management System (QMS) Policies, System Development Life Cycle and the business unit SOPs are followed.
The Quality Analyst will also review and approve business unit process maps, SOPs, Work Instructions, client communications, validation deliverables, and participate in project management. The Quality Analyst will perform system and process Risk Assessments in conjunction with the business.
Summary of Essential Job Functions
- Review and approve SOPs, Work Instructions, SDLC deliverables including requirements, test protocols, defect reporting, plans and reports by partnering with key stakeholders.
- Approval of end-to-end testing activities including reviewing development, testing, defect reporting and closure, and summary reports to ensure objectives and compliance requirements are met.
- Author planning, gap assessment, requirements and other SDLC documents as needed by partnering with key stakeholders to ensure defined business needs are met and in accordance with Quality Standards
- Provide Quality Management support during SDLC activities. Participate as needed in scrum meetings and development planning.
- Ensure requirements and processes comply with company global quality Management System policies and SOC 1 and SOC2 controls.
- Support and coordinate internal and client audits for the payments organization
- Provide guidance and support with remediation activities.
- Author Corrective and Preventive Actions (CAPAs) for the payments organization
- Monitor and support Continuous Improvement Activities
- Other duties as assigned
This position does not have supervisory responsibilities
Minimum Experience Requirements
- Bachelor’s Degree in IT, Business, Accounting, Finance or related area
- Strong knowledge of software testing and SDLC processes
- Experience with Pharmaceutical, Clinical Trial, and/or Financial Software Quality Management activities including:
- reviewing and approving quality deliverables of the SDLC process including user requirements, risk assessment, testing protocols
- reviewing and approving SOPs, Work Instructions.
- JIRA or other Agile Scrum management system
- coaching team members on quality policies and practices
- 3-5 years working in quality assurance/management in a regulated industry. SSAE16 or 21 CFR Part 11 experience is preferred.
- Previous quality process training experience is preferred.
- Previous participation in audits is preferred.
- Confident organized and detail oriented self-starter
- Ability to organize and present information in clear and concise formats
- Excellent problem-solving skills
- Exceptional collaboration and listening skills required
- Ability to quickly learn new concepts and tools is necessary
- Strong written and oral communication skills
- Ability to work independently in a global team environment to meet aggressive deadlines
Location: Wayne PA