Bringing Solutions that Make Business Better
IT Compliance Analyst
Clayton, NC – Full Time – Salary
Here’s what you can do :
The right candidate will serve as IT’s primary point of contact and subject matter expert (SME) on all IT and automation related compliance policies and programs. Candidate will become the site’s expert on implementation, training and support of eTIMS validation software. Candidate will also assist with the development and execution of key IT and automation projects.
You should be able to :
Work hours necessary to support continuous operations.
Interface with all business units to obtain/relay information.
Develop robust business relationships and contacts with outside vendors and contractors.
Travel overseas (estimated at 15% or less)
You can perform successfully in this position if you can :
In-depth knowledge and training on compliance policies, programs and procedures as well as regulatory requirements, such as 21 CFR Part 11, electronic records retention, configuration items lists, revalidation, etc.
Experience with quality procedures such as non-conformities, change requests, and IT system validation.
Serve as the liaison between IT/automation and both internal and external QA organizations as well other IT auditing organizations.
Knowledge of pharmaceutical manufacturing business processes and how IT and automation integrate with them.
Excellent troubleshooting skills; can identify root cause of a problem and assist in determining appropriate IT or technical solutions.
Demonstrated skills in identifying and leading medium to large scale IT validation projects.
Possesses and applies a broad range of expertise of principles, methods, practices, standards, procedures and compliance requirements of a particular business function in designing and developing complex IT solutions.
Provides solutions which are aligned with site strategies and comply with the company’s architectural and operating standards and requirements.
Experience with developing and maintaining IT-focused policies, procedures and other documents.
If you possess these minimum position qualifications, we should talk :
BS in IT, CIS, MIS, Engineering or other technical science field
5-10 years work experience
Experience with software development concepts
Proven experience with quality systems
Proven problem solving skills.
Excellent organizational skills.
Excellent written and verbal communication skills.
Knowledge of FDA regulations and guidelines as they relate to computer-based information systems
Experience working in pharmaceutical manufacturing environment
Add a call to action, for example:
Are you a fit? Click here or go to www.resolvit.com to register with our online talent community and apply for the position, then, follow up at 919-544-9422 or firstname.lastname@example.org .
What We Offer :
Full time employment
Health, Dental, Vision,
Short Term & Long Term Disability
401K with Matching
Click here to apply online
Resolvit, LLC - 11 months ago
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Resolvit, LLC is dedicated to providing technology and business consulting solutions to clients in the New York City, Washington, DC,...