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The Specialist, Quality Assurance is responsible for quality support functions related to product packaging for clinical and commercial batches. Key duties include batch record review, product release, compliance with FDA guidelines, participation in QA programs, and interaction with clients. The role demands adherence to Good Documentation Practices and support for efficiency improvement projects.
The Senior Financial Analyst provides critical financial support and oversight to operational leaders, assists in strategic planning, budgeting, forecasting, and driving financial decisions to enhance revenue growth and profitability. Responsibilities include month-end close, journal entries, SOX compliance, and audits.
The Scientist I, Analytical Research & Development role involves analysis of pharmaceutical products and materials, preparation of reagents, safe handling of compounds, disposal of waste, tabulation of results, writing analytical methods, and supporting material evaluation processes.
The Senior Manager of Supply Chain Analytics & Improvement leads a team to support end-to-end supply chain analysis and process improvement. Responsibilities include developing data analytical capabilities, creating Master Data Management elements, leading Continuous Improvement concepts, and managing network KPI reporting.
The Supervisor, Form Fill oversees daily activities in production, focusing on increasing efficiency and reducing waste. They manage a team, coordinate work activities, ensure safety and compliance with GMP standards, and lead continuous improvement initiatives.
The Scientist, QC is responsible for performing analytical testing, data analysis, and documentation to support ICH stability studies. The role includes operating cGMP equipment, writing technical documents, entering data into LIMS, maintaining laboratory standards, and managing records in TrackWise.
The Equipment Lead, Form Fill coordinates equipment operations in a cleanroom environment, overseeing the filling lines. Responsibilities include troubleshooting equipment issues, assisting manufacturing personnel, and ensuring compliance with safety and quality standards.
The Associate Scientist, QC is responsible for conducting release and identification testing of raw materials, operating Quality Control equipment, documenting test results, and maintaining laboratory standards. This includes data entry into LIMS, writing SOPs and reports, and ensuring compliance with cGMP regulations in a laboratory setting.
The Operator III, Formulation is responsible for measuring and formulating drug products according to batch records. Key tasks include aliquoting liquids and powders, performing sterile filtration, conducting integrity testing of product filters, and cleaning tanks with automated equipment.
The Sr. Compliance Specialist will manage and facilitate regulatory inspections and internal audits, ensuring compliance with quality standards and regulatory requirements. Responsibilities include oversight of audit responses, training, and collaboration with site experts to maintain adherence to Good Manufacturing Practices and related regulations.
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