Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Lead deviation/investigation activities involving production batch records, and support release of product for shipment. Oversee Functional Areas and site QA investigations to ensure they are complete. Lead Investigator personnel and othe

Receiving Functions Verify incoming shipments against Bill of Ladings, and Purchase orders for correct items, counts and contents. Receive incoming inventory and commodities directly in the AS400 computer system or by the use of scanning guns. Put away received inventory items in proper storage locations. Deliver received non inventory materials to end user community. Seg

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements. Manage assigned daily workload to meet requirements and perfor

Nature and scope Working as part of a multi disciplinary team, the Process Engineer must possess the ability to manage multiple tasks simultaneously, manage projects and project timelines, and create project specific documentation, drive project procurement, implementation, and project closure in an FDA regulated environment. This position will be required to develop proc

The Aseptic Technician IV role entails the execution of setup, breakdown, repairs, and preventive maintenance of equipment/systems used for conveying sterile containers and liquid filling of vials/ampules. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Setting up and breaking down ste

The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packagi

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Manage Preventative Maintenance/Calibration/Repair Program Prepare, maintain, and follow procedures for the maintenance, calibration, and metrology systems and associated processes to adhere to cGMP's, company, local and state requirement

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for the implementation, maintenance, administration and communication of American Regent's health & welfare benefit plans, work life balance policies, and retirement program. Responsible for collaborating with leadership on th

This Medical Director, Pharmacovigilance position will directly report to the Senior Medical Director, Head of Pharmacovigilance. This position is responsible for the accurate and timely reporting of product safety information to the organization and regulatory authorities world wide as assigned by the Head of Pharmacovigilance. Provide medical support to the PV team for

Duties Collaborate with IT to gather infrastructure and architectural requirements pertaining to relevant projects; Manage all project and compliance related issues associated with their project; May support, coordinate and interface with regulatory agencies as required in support of regulatory agency inspections; Support and maintain Quality programs, policies, processes

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under the direction of the QC Sr. Manager, supervise the environmental monitoring program. Review and sign as responsible individual all test data generated by the Environmental Monitoring Department or assign this task to qualified respo

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor. Maintains accurate and complete records. Maintains an accurate and complete Training Record. Abi

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Manage Formulation Development for New Products. Provide technical leadership for the design and execution of Quality by Design (QbD) product development studies and development of scalable manufacturing process for parenteral drugs. Mana

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Builds and develops enduring trusted partnerships through scientific engagement and exchange with KOL's and health care providers (HCPs) at the national, regional and local level Regularly collects and interprets medical insights and feed

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor. Maintains accurate and complete records. Maintains an accurate and complete Training Record. Abi