Valspec · 1 day ago
TrackWise Consultant
Raleigh, NC
Contract
Onsite
Senior Level
5+ years expValspec is a global provider of system validation and lifecycle services, specializing in the Life Sciences industry. They are seeking an experienced TrackWise Consultant specializing in Change Control to support on-site operations, ensuring regulatory compliance and operational efficiency in a GxP-regulated environment.
Software
No H1B
Responsibilities
Act as the on-site TrackWise Subject Matter Expert (SME) for Change Control processes
Configure, administer, and support TrackWise Change Control workflows, forms, business rules, and user roles
Manage the end-to-end Change Control lifecycle, including initiation, impact assessment, risk evaluation, approvals, implementation oversight, and closure
Partner closely with on-site Quality, Manufacturing, Engineering, Validation, and IT stakeholders to assess and implement changes in compliance with GMP and FDA requirements
Support and execute Computer System Validation (CSV) activities for TrackWise, including risk assessments, test script development, execution, and traceability
Author, review, and maintain quality documentation such as SOPs, work instructions, configuration specifications, and validation deliverables
Provide on-site user support and training, including troubleshooting system and process-related issues
Support internal and external audits and regulatory inspections by providing Change Control documentation, system demonstrations, and SME support
Drive continuous improvement initiatives for Change Control processes and system usability
Qualification
Required
Bachelor's degree in engineering, Life Sciences, Information Technology, or a related discipline
5+ years of hands-on experience with TrackWise in a GxP-regulated life sciences environment
Strong expertise in Change Control processes and electronic Quality Management Systems (eQMS)
Working knowledge of FDA and global regulations, including 21 CFR Parts 210, 211, and 11
Proven experience supporting CSV for quality systems
Ability to work full-time on-site and collaborate directly with cross-functional teams
Strong communication, documentation, and stakeholder management skills
Benefits
Premium medical coverage
401(k) with company match
Tuition reimbursement
Unique performance incentives
And more — all designed to support your growth, well-being, and future.
Company
Valspec
VALSPEC is the leading provider of computer system validation and system life cycle services including testing, commissioning, etc.
51-200 employees
Funding
Current Stage
Growth StageRecent News
2023-10-11
2022-11-11
Company data provided by crunchbase