Technician will be responsible for assembling, operating and monitoring a state of the art equipment in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of, and practice good aseptic technique to minimize potential for product contamination. Must also have some mechanical knowledge (hands on troublesh

Join us as a Chargeback Analyst is responsible for analyzing, researching, resolving, and trending chargeback discrepancies resulting in issuance of appropriate credits within Wholesaler / Distributor contractual terms. Chargeback Analyst is responsible for developing and maintaining strong collaborative relationships with Wholesaler / Distributor partners. Chargeback Ana

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

The Production Group Leader will be responsible for all daily operations of functional department without direct supervision on the shift. Responsible for training all employees on that shift, allocating resources, scheduling shift activity and insuring cGMP compliance in operation. This cross functional role is also responsible for assembling, operating, and monitoring s

Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individ

POSITION SUMMARY The Documentation Coordinator is responsible for the data processing of Change Notifications (CN) via Documentum, Document Change Requests (DCR), coordination of all controlled document implementation, update of SOP binder sets, control of document archival, and controlled document/logbook issuance, tracking, and reconciliation. The individual in the posi

Responsible for an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation, including troubleshooting. Independently executes protocols, verifications, method transfers in support of senior level personnel. Directs and provides guidance to associate scientists. Responsibilities Be able to articulate work related iss

A Scientist II in Quality Control displays an advanced knowledge in chromatographic techniques and instrumentation, and guides others in troubleshooting instrumentation and routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group. Responsibilities Principal Activities and Responsibilities Be able to articula

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities Visually inspec

The Validation Specialist works to support site validation technical experts on specific project teams. The Validation Specialist will participate in the development and execution of test plans for manufacturing equipment and processes, utilities, and facilities. The incumbent will contribute as a key validation representative in support of project team activities and pro

The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team (BLT). Leads local and collaborates

Responsible for the accurate weighing, checking and mixing of specific chemical compounds for product formulations; the calibrating and monitoring of a variety of mixing machinery and the accurate documenting and maintaining of production logbooks and records. They're also required to follow all departmental and company SOP's and maintain accurate and timely record keepin

1. Create excel spreadsheet to support Nitrosamine Risk Assessment for all US products 2.Data collection from various sources, such as SAP, Documentum/eDMS, Regulatory database, external manufacturer documentation 3.Needs to collaborate with various functions within the organization Compensation $20.50/hr $24.50/hr depending on level of education Responsibilities Student

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 wel

The Sr Principal Engineer performs sustaining engineering activities and technical project management related to disposables / consumable products for the Ivenix Infusion System portfolio. Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creat