Computer Systems Quality Assurance (CSQA)

Overview

On Site
$DOE
Full Time
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 2 day((s))

Skills

Quality Assurance
Reporting
System Testing
Enterprise Resource Planning
Manufacturing
Regulatory Compliance
Corrective And Preventive Action
Auditing
Inspection
Training
Computerized System Validation
QA Management
Risk Management
FOCUS

Job Details

Job Title: Computer Systems Quality Assurance (CSQA)

Location: Indianapolis, IN (Hybrid 3 days a week)

Duration: 12+ Months

Mandatory skills

  • IT CSV
  • IT QA / QA eCompliance Manager
  • Experience with global patient safety, adverse event/product complaint reporting

Job Description

This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client's ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards.

Key Objectives/Deliverables:

Maintain Inspectional Readiness

Ensure supported systems are validated

Ensure all quality actions and commitments for supported areas are appropriately tracked in

Quality/CAPA plans.

Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood

Ensure all Inspection Readiness materials are current and appropriate

Deliver Projects, Programs, and Support

Provide consulting and interpretation on client processes as related to the supported computer system

Provide training to customer areas on CSV-related topics as needed

Partner with Business, Business Quality, and IT customer areas to deliver business value

Understand customer, company, and Quality priorities

Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed

Engage customers and QA management in appropriate discussions of risk management

Ensure suppliers of computer systems or services meet quality expectations

Escalate computer system quality issues to the appropriate persons

Strive for and promote consistency within the CSQA Organization

Streamline and Continuously Improve

Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality

Identify opportunity for streamlining and simplification and assist in developing improved solutions

Understand external trends and potential ramifications for the supported IT area(s)

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.