Position Title: Risk Assessment / Technical Document Specialist
Work Location: Lexington, MA (Hybrid)
Assignment Duration: 12 Month contract with potential to extend
Work Arrangement: minimum 3 days a week onsite

Note:
For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.
 

Primary Duties

This contractor role is responsible for modernizing technical system documentation across Quality Control Lab Systems and performing structured data integrity risk assessments to enable risk-based optimization of procedural controls.

The consultant will partner cross-functionally with Quality, IT, and Business Process Owners to:

• Simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates
• Apply client's 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 

Responsibilities:

1. Technical Documentation Modernization (~50%)

• Assess 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

2. Data Integrity Risk Assessments & Control Strategy Optimization (~50%)

• 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:

• 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)
• Experience working cross-functionally in a matrixed organization

Key Skills, Abilities, and Competencies

• Strong knowledge of:
  • Data integrity regulations and expectations (ALCOA+, Part 11) 
  • Risk-based decision making and QRM methodologies 
• Ability to translate complex technical systems into simplified, user-friendly documentation
• 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

Other Job Requirements

• Role role requires on-site presence for workshops, risk assessments, and stakeholder engagement
• Strong proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio)

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $90.00/hr - $95.00/hr.