Position Overview
ProQuality Network is seeking a Validation Documentation & Remediation Analyst to support a critical remediation initiative within a regulated manufacturing environment. This role will focus on analyzing validation inventories, assessing documentation applicability, and identifying remediation needs across qualification and validation systems. The selected professional will play a key role in ensuring data integrity, documentation accuracy, and compliance with current validation standards and site requirements.
Primary Responsibilities
• Support validation inventory analysis and remediation assessments across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM).
• Utilize automated tools and data trackers to extract, organize, and analyze validation documentation.
• Review validation records to verify completeness, accuracy, and alignment with site practices and regulatory requirements.
• Evaluate documentation against Master Validation Plans (MVPs), Product Risk Assessments (PRAs), and supporting validation records.
• Identify gaps, discrepancies, outdated documentation, or missing records requiring remediation.
• Assess product and process validation records to determine remediation scope and impact.
• Ensure compliance with internal procedures, global validation standards, and remediation timelines.
• Escalate risks, data inconsistencies, and critical findings to project teams with clear recommendations for resolution.
• Support continuous improvement initiatives related to validation documentation management and remediation execution.
Qualifications
• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Minimum of 3 years of experience in validation, quality engineering, or manufacturing engineering within regulated industries.
• Hands-on experience with validation lifecycle activities, including OQ, PQ, TMV, and IPM.
• Strong knowledge of FDA-regulated, ISO, and GMP environments.
• Advanced proficiency in Microsoft Excel for data analysis and reporting.
• Experience working with document management systems (Windchill preferred).
Key Competencies
• Strong analytical thinking and problem-solving capabilities
• High attention to detail and commitment to data integrity
• Ability to interpret technical documentation and apply sound judgment
• Strong organizational and prioritization skills
• Effective communication and escalation management
• Ability to work independently in fast-paced, deadline-driven environments