Sr Analyst Quality Assurance
$94k - $151.8kJohnson & Johnson
Senior Quality Specialist at Johnson & Johnson leads investigation quality reviews, root-cause analysis oversight, and corrective action management in a regulated environment. The role ensures investigation robustness, compliance, and effectiveness while mentoring investigation teams and collaborating across functional areas.
Responsibilities
- Review investigation records for documentation completeness and robust root-cause analysis compliance
- Approve closure of investigation records and monitor action effectiveness and progress
- Provide coaching and feedback to investigation owners on best practices and system usage
- Compile investigation status updates, metrics reports, and trending analyses using data analytics
- Facilitate stakeholder collaboration, resolve cross-functional issues, and escalate risks to management
Requirements
- Bachelor's degree in life science or related discipline
- Minimum 6 years experience in regulated environment or investigations function
- Knowledge of regulatory compliance issues and quality management systems
- Strong analytical and problem-solving skills with attention to detail
- Excellent written and verbal communication abilities
- Experience with CAPA systems, investigative techniques, and data analytics
- Ability to work independently and coordinate across matrixed organizations
Vacancy posted 2 days ago
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