This is Sai Girish and I am a Staffing Specialist at LS Solutions, Inc. Kindly take a moment to review the details of the position
Supplier Quality Auditor – GxP Software Systems
Location: Chicago, IL (Remote Initially)
Duration: Long Term
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Work with cross-functional teams providing guidance regarding application of supplier quality procedures for auditing third party software vendors (e.g. ArisG)
- Perform direct and indirect supplier evaluation and selection activities, including supplier capability assessments and supplier quality systems/SDLC process audits.
- Participate in supplier audits to ensure Regulatory compliance to good practices and FDA regulations.
- Partner with IT and Quality for supplier qualification activities, including development software vendor qualification checklists and execution of those checklists via desk and onsite (if needed, post-COVID) audits.
- Review software releases and SDLC processes of software vendors – ensure they are maintaining their software in a state of control.
- Must have strong working knowledge of FDA Regulations, 21 CFR Part 11
- Must have experience auditing software vendors and ensuring they are compliant with Part 11 regulations
- CQA Certification preferred
- Experience implementing continuous improvement tools like Six Sigma or CQE strongly preferred
- Exhibits strong collaboration skills and the ability to develop/maintain productive relationships to assure success on both current and new business initiatives.
- Ability to combine data, good judgment, and intuition to drive improvements and make timely business decisions.
- Excellent time management skills and ability to multi-task and methodically manage project milestones.
- Excellent communication/interpersonal skills required (fluent in English language).
Sr. Talent Acquisition Specialist
LS Solutions, Inc.
Greater New York City Area
Direct: (609) 639-9609 / Fax: (609) 228-4034
Quality Assurance Auditor