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The Group Lead, Quality Assurance Documentation Systems is responsible for leading the Document Control, Records Center, and Systems Administration departments. They facilitate the implementation and maintenance of documentation systems, manage departmental processes, act as a subject matter expert for SOPs, and support regulatory inspections and quality metrics. Leadership experience and a strong background in Quality Assurance are emphasized.
The Specialist III, Quality Assurance is responsible for executing internal audits, facilitating customer audits, maintaining licenses, organizing documentation for regulatory submissions, and supporting improvements in the quality system. They must ensure compliance with regulatory requirements and lead initiatives for process improvements across departments.
The Global Lean Leader will implement lean methodologies across Catalent sites to improve safety, quality, cost, and delivery metrics. This role involves change management, training, coaching, and conducting workshops to facilitate the adoption of The Catalent Way. Frequent global travel is required to support manufacturing sites in driving continuous improvement initiatives.
The Lead Specialist, QA – Batch Disposition is responsible for providing quality assurance support for GMP documentation and ensuring compliance with regulatory standards. The role involves reviewing manufacturing activity documentation, interacting with the quality team, executing batch record reviews, evaluating product disposition, and compiling performance metrics.
The Principal Quality Assurance Representative will develop and implement sterility assurance and microbiology strategies at a pharmaceutical manufacturing facility, oversee compliance, assist in regulatory inspections, and ensure clean room controls to minimize contamination risks.
The Senior Financial Analyst at Catalent Maryland will analyze past financial performance, provide cost management, and support financial decision-making. The role requires a Bachelor's degree in accounting or finance, at least 3 years of experience, and proficiency in Microsoft Excel.
The Principal Quality Assurance Representative will lead efforts to develop sterility assurance and microbiology strategies at a pharmaceutical manufacturing facility, focusing on compliance, regulatory inspections, and contamination control to ensure a safe and effective manufacturing environment.
The Principal Specialist, Continuous Improvement will lead initiatives across the campus, focusing on building expertise, process standardization, and technology acceleration. Responsibilities include identifying improvement opportunities using Lean Six Sigma tools, coaching project leaders, facilitating problem-solving, and supporting CI training and communication within the organization.
The Senior Manager, QA will oversee the internal quality systems team, managing GMP processes, including change controls, deviations, and training. The role includes leading QA personnel, facilitating change control review boards, and managing the risk management process, among other responsibilities.
The Senior Manager, QC is responsible for overseeing chemistry activities, including analytical testing and data analysis, while ensuring compliance with quality standards and project timelines. They lead a team, collaborate with stakeholders, and handle revenue reporting.
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