Real Staffing are looking for a Quality Systems Analyst for a 6 month contract role (pending extension) based in Raritan New Jersey.
Please read the job description and experience sections carefully and apply accordingly.
- Review validation deliverables for projects which are contracted to third party suppliers.
- Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.
- Assist in planning, implementing, and documenting user acceptance testing.
- Review computerized systems validation documents such as:
- Risk Assessment
- Compliance Plan
- Requirements Specification
- Design Specification
- Test Plans
- Pre/Post Executed Test Scripts
- Test Summary Reports
- Data Migration Plan
- Traceability Matrix
- Compliance Report
- Release to Production Statements
- Manage and review testing.
- Provide guidance on quality issues that affect the integrity of the data or the system.
- Obtain and respond to QA review.
- Participate in establishing standard quality and validation practices.
- Independently assess compliance practices and recommend corrective actions.
- Approve validated computer system related change requests.
- Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.
- Monitor regulatory and inspection trends and advise the business on suitable action.
- Ability to create documents to an existing document standard.
- Able to develop all documentation required for a 21 CFR Part 11 validated project, including Compliance Plans and Summaries.
Education & Experience:
- 3 to 5 years' experience.
- Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes.
- Knowledge of SOPs and Industry Best Practices.
- Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
- Knowledge of IBM Rational Testing Tool.
- Advanced knowledge of complete MS Office suite and Visio.
- Firm understanding of technology platforms as needed for project.
- Experience with electronic document management systems (e.g. OpenText, Qumas, SharePoint etc.); application development and lifecycle management (e.g. PLM); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc.)
- Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
- Once trained, have the ability to work independently on CSV projects with minimal oversight.
Sthree US is acting as an Employment Business in relation to this vacancy.