Job Summary. The Risk Analyst is responsible for providing analytical support for claims related to workers compensation, auto, ocean marine, liability, and other lines of coverage. Manages and implements loss prevention and safety programs across the organization. Administers and monitors a wide variety of risk management and insurance program activities. This position interacts with all levels of employees throughout the company, including Seni...
Job Summary. The ISO Systems and Sustainability Manager is responsible for the management and maintenance of all the local requirements under ISO 14001 - Environmental Management System (EMS), ISO 45001 - Occupational Health and Safety Management System (OHSMS), and ISO 50001 - Energy Management System (EnMS) for the Plant (Production Unit) in accordance to the current ISO Standards, as well as all Sustainability initiatives. This role must colla...
Job Summary. This is a 3rd shift role in Melrose Park. Responsible for ensuring that the integrated fill line facilities, equipment and associated processes, as well as the quality processes that govern them, are effective, efficient, compliant and remain in a state of control. Responsible for evaluating for compliance and approval of Preventative Maintenance, Metrology, Validation and Qualification activities for the integrated fill line systems...
Job Summary. This position will be responsible for Supplier Quality in the Production Unit (PU). This position will ensure compliance to quality system requirements and drive the highest quality standards by helping to define specifications and by collaborating with suppliers. This role requires working in a cross-functional team environment with members of the R&D Design Centers, for example, as well as other members of the PU. This person appli...
Job Summary. This position will be responsible for Supplier Quality in the Production Unit (PU). This position will ensure compliance to quality system requirements and drive the highest quality standards by helping to define specifications and by collaborating with suppliers. This role requires working in a cross-functional team environment with members of the R&D Design Centers, for example, as well as other members of the PU. This person appli...
Job Summary. The Senior Principal Engineer, Infusion Systems, is a Systems Engineer with expertise managing product risk documentation for medical device products and collaborating with the broader R&D team to develop robust records for the Design History File. The engineer has responsibility for risk assessments and documentation for the Ivenix Infusion System during the product development process and throughout the product lifecycle. This role...
Job Summary. Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co-workers. This position reports to the packaging Supervisor and/or Group Leader and has no direct r...
Job Summary. Experienced Engineering position, leading the software design, coding, documenting, testing and maintenance of real-time embedded software and accessory software products. Plans and executes medium sized projects in compliance with standard operating procedure for medical device software development. Designs and implements architecture involving multiple software components complete with documentation and automated test suites for in...
Job Summary. Designs, develops, implements and supports all aspects of electrical control systems, equipment, and machinery related to site utilities, production equipment, and facilities. Is a technical resource to the Engineering, Maintenance and Validation departments to meet all regulatory and company specific policy requirements and to improve plant efficiency, capacity, and capability via continuous improvement and modernization objectives....
Job Summary. The Strategy Project Manager will lead development of strategic initiatives designed to improve the efficiency, value, and overall growth ambitions for the generics business. Subsequently, organize cross-functional teams to implement and execute such initiatives, and track progress. Leads international multidisciplinary teams charged with successful completion of projects required to transform BU Pharma in alignment with business obj...
Job Summary. POSITION SUMMARY. Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas. Responsibilities. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT. Drive a cul...
Job Summary. The Documentation Coordinator is responsible for processing document changes at the site, either via the electronic document management systems or vis paper-based Document Change Notices (DCNs). They also are responsible for binding, issuing, reconciling, and filing logbooks and laboratory notebooks, as well as for compiling documents for Annual Product Report Updates (APR), coordinating SOP implementation and update of SOP binder se...
