CSV Documentation SME in Lexington, MA

CSV Documentation SME in Lexington, MA Lexington, MA Apply Now Back to Search 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 Who We Are: The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort. Browse our website below for additional information on our company. The Fountain Group 3407 W Martin Luther King Jr. Dr. Tampa, FL 33607 “We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.” By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy Apply Now Back to Search Success! Your application was successfully sent! Error Apply Now Not yet ready to apply? Join our talent community