Sr QA Scientist

*Job Summary* * Advanced experience in Quality Systems, with demonstrated expertise in Change Control, Validation, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), and associated Quality documentation within a regulated GxP environment. * *Strong independent decision-making skills with the ability to influence others and drive alignment across teams. * * Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contribute to successful inspection outcomes. * *Proven ability to evaluate quality and compliance risks through risk-based decision making and drive cross-functional alignment to achieve compliant outcomes.* * Experience supporting drug product operations in a GMP-regulated environment. *Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices. * * Strong sense of accountability and ownership, with the ability to manage multiple high-impact Quality System deliverables simultaneously and deliver timely, compliant outcomes. * *Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks. * Ability to identify systemic quality signals, recurring process issues, and cross-functional process vulnerabilities through trend analysis, lifecycle monitoring, and prior event assessment. * *Experience supporting Change Controls, Validation activities, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR). * * Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI-enabled tools) to improve Quality System effectiveness. * Bachelors Degree in LifeSciences, must have excellent communication (read, write & Speak) in English & Spanish. Pay: $35.00 - $48.00 per hour Work Location: In person