Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for ensuring current and complete costing of the site's raw material, work in process and finished goods inventories Assist in performing periodic review of the site's standard material, labor and overhead costs to include rec

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Support Preventative Maintenance/Calibration/and Repair Workflow Serve as site owner and subject matter expert of Computerized Maintenance Management System (CMMS.) Ensure that maintenance and calibration procedures are entered into CMMS.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform Calibrations Follow written calibration procedures. Accurately complete calibration paperwork, including work orders and logbooks in accordance with existing company policies, procedures, Current Good Manufacturing Practices, heal

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Coordinate sample delivery and receipt activities with Production Operations, any American Regent site, or any 3rd party CMO. Responsible to ensure that all finished product samples received by the R&D Group are, upon receipt, properly ha

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Supervises manufacturing activities as defined by established operating procedures for multiple products on a daily and weekly basis by delegating resources as well as participating in the process. Responsible for the training and mentori

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Plan daily workload to meet requirements. Conduct environmental monitoring activities including air (Viable and Non viable), surface and personnel inside the sterile manufacturing areas. Conduct water sampling throughout facility. Perform

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 inspection and packaging lines Troubleshooting equipment/system issues Performing equipment preventive maintenance Identifying and correcting unsafe conditions Work in a safe manner using the proper Personal P

Execute and document preventive maintenance tasks (e.g. filter replacements, oil changes, lubrication, gasket replacement) per the maintenance schedule and applicable Standard Operating Procedures (SOPs) and cGMP (Current Good Manufacturing Practices) guidelines. Execute and document corrective maintenance on an as needed basis per applicable SOPs and cGMP guidelines. Tro

Execute and document preventive maintenance tasks (e.g. filter replacements, oil changes, lubrication, gasket replacement) per the maintenance schedule and applicable Standard Operating Procedures (SOPs) and cGMP (Current Good Manufacturing Practices) guidelines. Execute and document corrective maintenance on an as needed basis per applicable SOPs and cGMP guidelines. Tro

Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures. Adheres to good manufacturing practices, (GMP & cGMP). Perform duties according to the company's standard operating procedures, (SOPs). Operates washer and capper machines used in department. Accurately counts work done and keeps ne

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Aseptically weigh and measure materials needed for the formulation of products utilizing balances, scales, load cells, flasks, graduated cylinders, prepare raw material for sterilization, collect samples from bulk solutions, etc. Utilize

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Set up and operation of vial washing and capping machinery, including removal, proper installation, and verification of change parts. Utilize testing equipment to verify quality of filled vials including seal force tester and headspace an

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The incumbent will act as a Subject Matter Expert (SME) for a designated discipline/s. Focusing on Packaging, Equipment and Facilities and/or Cleaning Validation, the incumbent will develop and execute validation protocols associated with

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. 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

Utilize warehouse mobility system to track/log movement of material from warehouse through manufacturing. Accurately completes all documentation associated with tasks performed. Keeps work/staging areas clean and orderly. Follow directives issued by leads and supervisors. Ability to prioritize and complete required tasks efficiently. Performs routine cleaning of productio