V-Soft Consulting is currently seeking a?Sr IT Test Analyst (Pharmaceutical/ Medical)?for our premier client in?Elkton, Maryland. This is a contract role, 100% remote!
Education and Experience ?
- Bachelor’s degree in an applicable science
- At least 3 years of progressively responsible IT and/or QA experience.
Experience with the following software systems/applications:
- ERP
- Change management
- Configuration management
- Product lifecycle management
- Laboratory information management
- Mobile
- Middleware
- Business intelligence
- Master data management
- Manufacturing execution systems.
Knowledge, Skills and Abilities ?
- Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, ISO13485:2003, EU GMP
- Annex 11 and the European and Canadian Medical Device Directives
- Demonstrated experience in product risk management (ISO 14971)
- Understanding of current software quality techniques and industry standards such as ISO, IEEE, AAMI, and GAMP
- At least 3 years of experience in a quality assurance, information technology, or automation and computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry
- Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques
- Understanding of current software quality-assurance techniques and software industry standards and their impact on internal procedures, and software quality
- Demonstrated project management and leadership skills
- Excellent written and oral communication skills
- Proficiency in interacting with contacts, including project teams and vendors
- Highly motivated and assertive
- Demonstrated ability to work in a dynamic team environment.
- Ability to: Handle multiple projects and priorities with competing resources
- Communicate clear direction, commitments, and alignment
- Partner broadly, Be both flexible and determined, Train others
- Participating with stakeholders in the preparation of software and hardware specification documents and test plans
- Participating in developing software quality assurance processes and implementing standard operating procedures. Developing and delivering training programs in support of software testing concepts, practices, and requirements
- Developing and implementing effective corrective and preventive actions
- Authoring, reviewing, and/or approving system change, configuration management, and supporting documentation activities
- Preparing for and participating in external/internal computer system/software audits
- Contributing to process improvements by developing and updating written procedures related to computer systems testing
- Supporting and monitoring defect resolution
- Supporting and monitoring the qualification of Information Technology Infrastructure Platforms
- ?Ensuring that test cases are documented and executed following the requirements set forth by procedures and external requirements
- Providing leadership, oversight, and training related to test case development to multi-functional teams
- Providing oversight for test cases used in the validation of software, hardware, and networks, including risk-based approaches
- Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements Working with appropriate teams to establish quality expectations related to test planning and execution
- Develops, implements and maintains policies, procedures, programs and the overall plan for ensuring the security and integrity of company data, databases, information systems, and technology.
- Conducts risk management analysis and creates disaster recovery plans.
Qualified candidates should apply or send their resume to?[email protected]
V-Soft Consulting is a trusted partner with experience across diverse technology stacks to help business get IT done. What makes V-Soft different? Our expertise is derived from over 20 years of delivering world-class IT staffing, consulting, engineering and managed services to Fortune 1000 and mid-market companies in the U.S., Canada, and Asia.
V-Soft is headquartered in Louisville, KY with strategic locations in India, Canada, and across the U.S., including Madison, Chicago, Denver, Harrisburg and Atlanta. V-Soft has been recognized among the top 100 fastest growing staffing companies in North America, and is known for the ability to provide highly qualified consultants for any project at any scale. V-Soft has a wide variety of partnerships across diverse technology stacks, and holds such titles as MuleSoft Certified Delivery Resource, Oracle Gold Partner, ServiceNow Partner, Microsoft Partner, and Cisco Registered Partner, amongst many others.
Like what you hear? Apply with V-Soft today! For more information or to view all our open jobs, please visit www.vsoftconsulting.com or call (844) 425-8425.
