Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry
Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
Must have change management experience, preferably ServiceNow change management experience
Previous experience supporting computer system qualification efforts including authoring, executing and reviewing qualification deliverables
Experience with electronic document management systems (DocIT) and testing applications such as HP ALM/HP Quality Center is a plus
Position responsibilities include:
Working with the Hosting Services and Cloud Hosting Services teams to assess new and existing infrastructure components/resources installations (server, DB and storage) and application tool installations and upgrades.
Execute the qualification process as applicable, ensuring change requests are submitted per BMS policyProviding infrastructure qualification knowledge transfer to the Enterprise Service Providers for component level resources (server, database and storage qualification requirements) and application toolsets, and assistance with the creation or modification of related documentation
Performing ongoing quality review, monitoring and approval of related change tickets for the implementation and maintenance of such component level resources and applications
Ensure any deviations are documented, remediated and closed
Track and ensure qualified assets have an appropriate disposition
Ensure the qualification of infrastructure software or applications that interface/impact GxP applications
Ensure qualification documentation is efficiently managed and available for inspection
Providing Audit and Inspection request for infrastructure-related information and response knowledge transfer, assistance with the creation or modification of related documentation, and review/oversight of "live" requests/responses
Participate in status calls representing IT Quality Management
Serve as a qualification subject matter expert
Maintains close communication with stakeholders and team members to keep apprised of status and timelines
Reports status to management
Assist in the preparation of summary report
Qualifications
Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry
Technically conversant in infrastructure concepts and techniques related to infrastructure toolsets, server rooms/data centers, servers, databases & storage
Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
Must have change management experience, preferably ServiceNow change management experience
Previous experience supporting computer system qualification efforts including authoring, executing and reviewing qualification deliverables
Strong oral and written communication skills in English
Proficiency in MS Office suite
Experience with electronic document management systems (DocIT) and testing applications such as HP ALM/HP Quality Center is a plus
Open to creative, innovative, flexible and practical approaches to improving practices and solving problems
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Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Company Profile:
Beacon Hill Technologies, a premier National Information Technology Staffing Group, provides world class technology talent across all industries utilizing a complete suite of staffing services. Beacon Hill Technologies' dedicated team of recruiting and staffing experts consistently delivers quality IT professionals to solve our customers' technical and business needs.
Beacon Hill Technologies covers a broad spectrum of IT positions, including Project Management and Business Analysis, Programming/Development, Database, Infrastructure, Quality Assurance, Production/Support and ERP roles.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
