The Quality Assurance Associate is responsible for providing QA support for Client Projects and GMP Operations from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption.
The Project Manager (PM) will lead client Process Development and GMP Manufacturing projects. The PM is responsible for managing the client contract and will use their organizational, collaboration, influencing and leadership skills to initiate, plan, execute and monitor client projects.
The Director, Validation will have the opportunity to establish and further the Paragon Validation Policy with collaboration from key stakeholders while playing a prominent role in setting the strategy and direction for the Paragon Validation Program.
The Manufacturing Compliance Manager manage the compliance function within Manufacturing and is responsible for the batch records lifecycle throughout the manufacturing plant. Once documents have been created and approved, the incumbent will be responsible for tracking the lifecycle of batch records and documents to support manufacturing activities.
The Manager of GMP Manufacturing for Upstream Processing is responsible to lead a team of professional while overseeing the GMP manufacturing process, through the broad knowledge of theories and principles utilized to solve operational.
Requires broad knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of a variety of proteins, antibodies, etc. for Phase I/II GMP manufacturing.
Provide strategic oversight of the training and document control systems ensuring phase appropriate processes to support Phase I/II operations with the ability to scale to support Phase III/commercial operations.
The Manager, Manufacturing Training will provide, document, and maintain, training for all manufacturing personnel on matters including but not limited to: new hire orientation, department and facility specific training.
The Regulatory Affairs Leader will be responsible for supporting clients, US and EU regulatory submission strategies. He/She will be responsible for drafting and reviewing submission documents and interacting with our clients.
Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a routine basis.Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements.