Senior GxP Systems Specialist
5 days ago
**Job Summary**
We are seeking a highly skilled Senior GxP Systems Specialist to join our team at Insight Global. In this role, you will be responsible for the management of GxP applications throughout the system lifecycle, including day-to-day troubleshooting, application support, system administration, and compliance with regulatory requirements.
The ideal candidate will have a minimum of 8 years of hands-on technical IT experience, with at least 5 years of experience supporting GxP computerized systems in the biopharmaceutical/pharmaceutical industries. A strong understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems is essential.
In addition to your technical expertise, you will possess excellent communication and interpersonal skills, with the ability to work independently and efficiently with minimal supervision. If you are a proactive team player who gets along easily with others and enjoys collaborating, we encourage you to apply.
Key Responsibilities
- Support the system administration of GxP applications, including MasterControl, Trackwise Digital, Tracelink, Part 11 DocuSign, Veeva, Argus, and other industry-standard platforms/systems.
- Analyze, design, develop, and install GxP applications in accordance with established SOPs.
- Prepare, review, and approve GxP Computerized Systems Validation lifecycle documents as an IT GxP SME.
- Provide technical support to employees at all levels of the organization.
- Participate in Project Meetings and serve as a Project Manager as needed.
Requirements
- At least 8 years of hands-on technical IT experience.
- Minimum additional 5 years of experience supporting GxP (GMP, GLP, GCP) computerized systems in the biopharmaceutical/pharmaceutical industries.
- Associate's degree in a related field or relevant experience.
- Full understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems.
- Familiarity with System Development Lifecycle and GAMP5 methodology.
- Excellent communication and interpersonal skills.
Salary Range:** $120,000 - $160,000 per year
Insight Global offers a competitive salary range, commensurate with experience, plus benefits, opportunities for growth and development, and a dynamic work environment. We are committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.
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