Technical Consultant # 26-15672

Job Overview

Primary Duties

• Simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates
• Apply global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access management
• Provide recommendations to optimize the frequency and design of controls

Technical Documentation Modernization

• Audit current-state system documentation across QC GxP systems
• Redesign and standardize documentation structure aligned to SDLC and validation expectations (e.g., FRS, SDCS, SOPs) and global templates
• Ensure documentation aligns with: 21 CFR Part 11, Data integrity expectations, Internal validation, SDLC and QMS standards
• Partner with system owners and SMEs to validate accuracy and usability of modernized documents
• Identify opportunities to digitize, automate, or rationalize documentation and lifecycle processes in collaboration with QC IT team

Data Integrity Risk Assessments & Control Strategy Optimization

• Facilitate and execute structured risk assessments using QRM principles (e.g., ICH Q9 methodologies)
• Evaluate data integrity risks across system processes, including: Administrative Audit trail Reviews, User access and privileges, Data backup and restore
• Assess the effectiveness, redundancy, and burden of existing controls
• Develop risk-based recommendations for: Adjusting frequency of audit trail reviews, Optimizing backup/restore verification approaches, Rationalizing user account management processes
• Document risk assessments with clear: Risk statements, Impact/severity scoring, Detectability and mitigation strategies
• Support development of remediation or optimization plans based on findings
• Align outputs with site DI program expectations and governance forums

Education

• Bachelor’s degree in Science, Engineering, Information Technology, or related field (required)
• Experience in GxP-regulated pharmaceutical or biotech environments (required)
• Demonstrated experience with: Technical system documentation (FRS, SDCS, SOPs), Computerized Systems Validation (CSV) and system lifecycle management
• Experience leading or facilitating Quality Risk Management activities (preferred)
• Strong understanding of data integrity principles and regulatory expectations (required)
• Experience performing data integrity assessments or remediation activities (preferred)

Key Skills, Abilities, and Competencies

• Strong knowledge of: Data integrity regulations and expectations (ALCOA+, Part 11), Risk-based decision making and QRM methodologies
• Expertise in evaluating system controls (audit trails, access, backups, interfaces)
• Strong facilitation skills for risk assessments and cross-functional workshops
• Analytical thinking with ability to challenge legacy practices and drive simplification
• Effective communication skills across technical and non-technical stakeholders
• Ability to operate independently with minimal oversight in a fast-paced environment

Complexity and Problem Solving

• Applies risk-based judgment to evaluate compliance vs. operational efficiency trade-offs
• Makes recommendations that may significantly change control strategies or reduce operational burden
• Balances regulatory expectations with pragmatic, scalable solutions
• Works across multiple systems, functions, and stakeholders simultaneously

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer.