Sr. Analyst, IT Validation Services

Overview

Remote
On Site
Hybrid
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Contract - 12+ mo(s)

Skills

Design Of Experiments
DMS
Risk Assessment
Test Plans
Test Scripts
IQ
OQ
PQ
Test Execution
Collaboration
System Testing
Auditing
Information Technology
Training
Change Management
Systems Engineering
Software Development Methodology
Computerized System Validation
Communication
FOCUS
Documentation
GDP
Software Packaging
Microsoft Outlook
Microsoft Excel
Microsoft PowerPoint
SAP
LIMS
Distribution
Veeva
ServiceNow
Pharmaceutics
Manufacturing
Supply Chain Management
Project Management
Budget
Regulatory Compliance
Management
Supervision
SANS
Health Care
Legal
Insurance

Job Details

Job Title: Sr. Analyst, IT Validation Services
Location: Remote
Duration: 12 Months
Pay Range: $30/hr-$35/hr on W2 (DOE)

Primary Responsibilities
  • Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls:
    • Validation Plans/Summary Reports
    • Risk Assessments
    • User Requirements
    • Specifications
    • Test Plans
    • Test Scripts: IQ, OQ or PQ
  • Assess and implement the most effective validation strategy for each activity.
  • Oversee test execution for cross-functional teams, including training, tracking, and reviews.
  • Build strong relationships with business counterparts to understand processes and requirements, ensuring delivery of compliant computer system solutions.
  • Work effectively with IT colleagues to ensure compliance with validation processes and proper documentation.
  • Collaborate with Information System Quality Assurance (ISQA) to ensure compliance on all projects, procedures and audits related to Information Technology.
Education and Experience
  • BS/Equivalent Training/Certification and minimum of 5 years of relevant experience in computer systems validation, change management and systems development life cycle methodologies.
Necessary Knowledge, Skills, and Abilities
  • Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies and CSV regulations, standards, and best practices
  • Working knowledge of Computer Software Assurance (CSA) guidance and its applicability.
  • Excellent written and verbal communication skills with a focus on Good Documentation Practices (GDP).
  • Technical knowledge of the following computer systems and software (at a minimum):
  • MS software packages such as Outlook, Word, Excel, PowerPoint and MS Project
  • SAP, LIMS, or other Manufacturing, Distribution and Laboratory systems
  • Veeva Vault
  • ServiceNow
  • Robust knowledge and understanding of pharmaceutical manufacturing, packaging, operations, quality, and supply chain processes and related systems.
  • Working knowledge of project management principles, and ability to operate under tight timelines, within budget and to specified quality and compliance goals.
  • Solid relationship and conflict management skills, and ability to navigate complex, fast-moving, business environments in a self-directed manner.
  • Supervisory Responsibilities (if applicable):
  • There are no supervisory responsibilities expected in this position.
Benefits Info: Russell Tobin/Pride Global offers eligible employee s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.
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