Jobs in All Categories (17) Accounting & Finance (1) Human Resources & Legal (1) Operations & General Management (3) Project Management (1) Science & Education (10) Technology (1)
Manages document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as, regulatory requirements.
Maintain databases and systems used for tracking various GMP manufacturing associated support activities.
Identifies and resolves internal Paragon quality control microbiological testing issues; ensures compliance with cGMP and safety requirements within the QC microbiological laboratory.
Works to continue to develop project management competencies across the company while strengthening the support capabilities of Project Management.
Generation or oversight of CSV protocols for both enterprise-level and laboratory systems; serve as CSV SME for all client-related issues/concerns dealing with this topic.
Help develop and formally document supply strategies and processes including purchasing and GMP warehouse operations.
Development of process steps for production of analytical virus and cell banks; analytical development of in process assay and release assays, and assay qualification.
Provides oversight and scheduling of QA Operations to ensure quality objectives are attained related to client projects and internal projects.
Initiation of change controls to determine impact of changes to facility, utilities, equipment, process/product as applicable, and system owners.
Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
Contamination control planning and implementation with a focus on sterility assurance and generating products under controlled conditions.
Works closely with senior management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives.
Responsible for batch record development and execution, as well as managing a team of professional manufacturing associates.
Responsible to drive financial results, analyze trends and drive analytics through proprietary reporting systems for contracts.
Complies with federal, state, and local legal requirements by studying existing and new legislation; obtaining qualified opinions; enforcing adherence to requirements; advising management on needed actions.
Accurately maintains/completes all equipment logbooks and maintenance records within a software maintenance management program; works closely with manufacturing/lab staff to troubleshoot and repair equipment problems.
Participation in decision-making processes within the project team by actively engaging in scientific and technical discussions.