COMPUTER VALIDATION COMPLIANCE SPECIALIST

 

BH: 3478594

 *** MUST BE ABLE TO WORK ON A W/2 HOURLY BASIS (without Sponsorship) *** NO C2C *** REMOTE & ON SITE BLEND ***

 

Our Client is expanding and currently seeks a

 

COMPUTER VALIDATION COMPLIANCE SPECIALIST

 

For a 6+month assignment with possible extensions!! 

 

LOCATION:  Princeton, New Jersey

 

Position is currently remote, but must report to an office once safe to do so.

 

Leverage your VALIDATION & HP ALM skills

to help take your career with our Client to

the "Next Level" for 2021 and beyond!    

Our Client is seeking a Computer Validation Compliance Specialist to become part their Compliance department.

A key focus of this role will be to provide quality/compliance oversight to all computer system validation related activities across the enterprise.

Overview:

• 3+ years’ related experience.
• Direct 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.
• 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 Validation Plans and Summaries.

 

Responsibilities:

• Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes.
• Follow 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.
• Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.
• 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:
• Requirements Specification
• Design Specification
• CSV Risk Assessment
• Test Plans
• Test Summary Reports
• Data Migration Plan
• Pre/Post Executed Test Scripts
• Traceability Matrix
• Release to Production Statements

Knowledge of:

• 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. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); 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.
• Ability to perform in a highly matrixed organization structure.

 

Experience & Education:

• Bachelor’s degree in a related field from an accredited college or university.

 

 

Important information:

• There is no per diem with this position
• There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
• MUST be able to work without sponsorship or VISA transfer for this position.

EMAIL:   

Why Kelly®?

By partnering with Kelly® Technology, you’ll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today’s most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We’re here to help you gain experience, keep learning, and move your career forward.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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