CSV Documentation SME in Lexington, MA

The Fountain Group; Lexington (MA); Hybrid; USD 136,382 - 140,515; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

Disability insurance

Hybrid work arrangement

Job summary

The Fountain Group is seeking a qualified candidate in Lexington, MA to act as a subject matter expert across IT systems and data integrity. The role emphasizes compliance, risk assessment, and documentation modernization within QC lab environments.

You will partner with Quality, IT, and business owners to optimize controls, align with 21 CFR Part 11, and drive remediation or optimization plans as needed.

Qualifications

• Bachelor's degree in Science, Engineering, IT, or related field.
• Experience in GxP-regulated pharmaceutical or biotech environments.
• Knowledge of CSV and system lifecycle management.
• Familiarity with data integrity regulations (ALCOA+).
• Ability to facilitate Quality Risk Management activities.

Responsibilities

• Serve as SME across IT systems and data integrity for compliance.
• Modernize system documentation across QC lab systems.
• Perform structured risk assessments using QRM/ICH Q9 principles.
• Advise on audit trails, backup/restore, and user access controls.
• Collaborate with Quality IT and Process Owners to optimize controls.

Skills

Quality Risk Management

Data integrity principles

Regulatory compliance

Cross-functional collaboration

Documentation standardization

Education

Bachelor's degree in Science/Engineering/IT or related field

Tools

CSV

FRS/SDCS

SOPs

SDLC

Job description

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.

Primary Duties

• 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

Responsibilities

• 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

Requirements

• 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