Risk Assessment / Technical Document Specialist

POSITION TITLE: Risk Assessment / Technical Document Specialist

This role will serve as a SME across both IT systems and data integrity, ensuring solutions are compliant, inspection-ready, and operationally efficient.

12 Month contract with potential to extend

Onsite Expectations: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 DutiesThis 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 templatesApply the client global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access managementProvide recommendations to optimize the frequency and design of controlsResponsibilities

1. Technical Documentation Modernization (~50%)Assess current-state system documentation across QC GxP systemsRedesign and standardize documentation structure aligned to SDLC and validation expectations (e.g., FRS, SDCS, SOPs) and global templatesEnsure documentation aligns with:21 CFR Part 11Data integrity expectationsInternal validation, SDLC and QMS standardsPartner with system owners and SMEs to validate accuracy and usability of modernized documentsIdentify 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 ReviewsUser access and privilegesData backup and restoreAssess the effectiveness, redundancy, and burden of existing controlsDevelop risk-based recommendations for:Adjusting frequency of audit trail reviewsOptimizing backup/restore verification approachesRationalizing user account management processesDocument risk assessments with clear:Risk statementsImpact/severity scoringDetectability and mitigation strategiesSupport development of remediation or optimization plans based on findingsAlign outputs with site DI program expectations and governance forumsEducation and Experience RequirementsEducationBachelor s degree in Science, Engineering, Information Technology, or related field (required)ExperienceExperience in GxP-regulated pharmaceutical or biotech environments (required)Demonstrated experience with:Technical system documentation (FRS, SDCS, SOPs)Computerized Systems Validation (CSV) and system lifecycle managementExperience 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 organizationKey Skills, Abilities, and CompetenciesStrong knowledge of:Data integrity regulations and expectations (ALCOA+, Part 11)Risk-based decision making and QRM methodologiesAbility to translate complex technical systems into simplified, user-friendly documentationExpertise in evaluating system controls (audit trails, access, backups, interfaces)Strong facilitation skills for risk assessments and cross-functional workshopsAnalytical thinking with ability to challenge legacy practices and drive simplificationEffective communication skills across technical and non-technical stakeholdersAbility to operate independently with minimal oversight in a fast-paced environmentComplexity and Problem SolvingApplies risk-based judgment to evaluate compliance vs. operational efficiency trade-offsMakes recommendations that may significantly change control strategies or reduce operational burdenBalances regulatory expectations with pragmatic, scalable solutionsWorks across multiple systems, functions, and stakeholders simultaneouslyOther Job RequirementsRole role requires on-site presence for workshops, risk assessments, and stakeholder engagementStrong proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio)