CSV Analyst / QA System Validation Supervisor - Alpharetta, GA

[Sid K]

Hi Folks,

My client is looking for CSV Analyst / QA System Validation Supervisor for a 12 Month Contract position in Alpharetta, GA

Position: CSV Analyst / QA System Validation Supervisor
Location:  Alpharetta, GA
Duration: 12 Month Contract

 

Key Responsibilities

• Update validation procedures including change control, training, and audit processes to maintain system validation.
• Write and review validation documentation such as validation plans, URS, FRS, risk assessments, traceability matrices, IQ/OQ/PQ/OPQ protocols, and reports.
• Support system validation project activities including protocol writing, test script review, and validation reporting.
• Review and approve change control requests and assess their impact on system validation status.
• Review and approve procedures, forms, and manuals related to validated systems.
• Perform audit trail reviews and document findings.
• Evaluate system validation status and generate corresponding reports.
• Assist in supplier qualification assessments and data gathering.
• Investigate and resolve deviations, nonconformances, CAPAs, and audit findings.
• Maintain document management systems to ensure availability of required documentation for audits and inspections.
• Support internal and external audits and validation project status reporting.
• Provide guidance to IT and Engineering teams to maintain validation of warehouse and support systems used in healthcare applications.
• Identify systems requiring validation and assess their compliance needs.
• Collaborate with internal teams to resolve healthcare compliance issues.

 

Required Qualifications

• Bachelor’s degree in Information Technology, Information Security, or a related field.
• Alternatively, eight years of relevant work experience may be substituted in lieu of formal education.
• 8+ years of experience in QA system validation.
• Strong knowledge of 21 CFR Part 11, Annex 11, and GAMP 5.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Experience supporting large IT environments and system deployments.
• Expertise in Linux, Windows, and network security protocols

 

Preferred Qualifications

• Experience with SIEM analysis and reporting.
• Familiarity with security frameworks such as NIST, CSF, CJIS, IRS 1075, CMS MARS-E.
• Knowledge of application security (AppSec).
  
  Thanks
  Sid