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Technical Documentation Specialist (GxP / CSV / Data Integrity)

Intellectt INC

Lexington, MA

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Code of Federal Regulations, Cross-Functional, Data Analysis, Data Quality, Documentation, GxP, Information Technology & Information Systems, Laboratory Management, Laboratory Systems, Leadership, Matrix Management, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Visio, Microsoft Word, Quality Control, Quality Management, Regulations, Risk, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), Structured Data, Support Documentation, System Lifecycle, System Validation, Systems Administration/Management, Technical Writing
LOCATION
Lexington, MA
POSTED
1 day ago

Job Description

We are seeking a Risk Assessment / Technical Documentation Specialist to support Quality Control Lab Systems in a GxP-regulated pharmaceutical or biotech environment. This role will serve as a subject matter expert across IT systems and data integrity, ensuring solutions remain compliant, inspection-ready, and operationally efficient. The selected candidate will modernize technical system documentation and perform structured data integrity risk assessments to enable risk-based optimization of procedural controls. This is a hybrid opportunity requiring onsite collaboration three days per week while working cross-functionally with multiple teams throughout the system lifecycle.

Key Skills

  • Technical system documentation (FRS, SDCS, SOPs)
  • Computerized Systems Validation (CSV)
  • System lifecycle management
  • Quality Risk Management (QRM)
  • Data Integrity
  • ALCOA+
  • 21 CFR Part 11
  • Risk-based decision making
  • Data integrity assessments
  • Data integrity remediation activities
  • Evaluation of system controls including audit trails, user access, backups, and interfaces
  • Technical documentation simplification
  • Cross-functional collaboration
  • Risk assessment facilitation
  • Microsoft Word, Excel, PowerPoint, and Visio

Required Qualifications

  • Bachelor's degree
  • Experience in GxP-regulated pharmaceutical or biotech environments
  • Demonstrated experience with technical system documentation (FRS, SDCS, SOPs)
  • Experience with Computerized Systems Validation (CSV) and system lifecycle management
  • Experience leading or facilitating Quality Risk Management activities
  • Strong understanding of data integrity principles and regulatory expectations
  • Strong knowledge of ALCOA+ and 21 CFR Part 11 requirements
  • Proficiency with risk-based decision making and Quality Risk Management methodologies
  • Ability to translate complex technical systems into simplified, user-friendly documentation
  • Expertise in evaluating audit trails, system access, backups, and interfaces
  • Experience working cross-functionally in a matrixed organization
  • Strong facilitation skills for risk assessments and cross-functional workshops
  • Strong proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)

Additional Skills

  • Experience performing data integrity assessments or remediation activities (preferred)

About the Company

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Intellectt INC