CSV Documentation SME in Lexington, MA

Pay & Benefits

Pay: $99-102/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance.

Hybrid role: 3 days onsite at a minimum after onboarding and training (during this time onsite is expected 5 days/week).

W2 Candidates only; 1099/C2C cannot be considered.

• This role will serve as a SME across both IT systems and data integrity, ensuring solutions are compliant, inspection-ready, and operationally efficient.
• 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.
• Will partner cross-functionally with Quality, IT, and Business Process Owners to:
• Will simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates
• Role will 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

• 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, and 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.
• 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, and rationalizing user account management processes.
• Document risk assessments with clear Risk statements, Impact/severity scoring, and detectability and mitigation strategies.
• Support development of remediation or optimization plans based on findings
• Align outputs with site DI program expectations and governance forums

• Bachelor’s degree in Science, Engineering, Information Technology, or related field (required)
• Experience in GxP-regulated pharmaceutical or biotech environments (required)
• 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
• Data integrity regulations and expectations (ALCOA+, Part 11)
• Risk-based decision making and QRM methodologies