Include (but are not limited to) Test, calibrate, and repair mechanical, electromechanical, and electronic measuring, recording, and indicating instruments and equipment for conformance to established specifications. Review of appropriate calibration records and documents. Must be able to perform computer operations for accessing SOP Documentation, and Computerized Mainten

Include (but are not limited to) Inspection along with some, labeling and package finished products (sterile liquid medicine) Operate Finishing equipment Adhere to finishing procedures and PDA guidelines Accurately document data and complete any corresponding paperwork Contribute to maintaining an FDA compliant facility Full job description available during formal intervie

Include (but are not limited to) Inspection along with some, labeling and package finished products (sterile liquid medicine) Operate Finishing equipment Adhere to finishing procedures and PDA guidelines Accurately document data and complete any corresponding paperwork Contribute to maintaining an FDA compliant facility Full job description available during formal intervie

Include (but are not limited to) Solve complex analytical problems, as well as recommending and implementing continuous laboratory improvements. Provide documentation support for analytical services (i.e. Test Methods, Specifications, Validation Protocols, and Summary Reports). Capable of executing test method feasibility, development, and validation campaigns for client p

Include ( but are not limited to ) Manage day to day prioritization of routine, in process, stability and finished product testing. Manage day to day support of operations related to environmental monitoring and monitoring of critical utilities. Lead training of all new employees and maintain all training documentation via current system. Support the EIR system and assist

Include ( but are not limited to ) Perform sampling of water and pure steam to support manufacturing activities. Perform Environmental Monitoring of isolator and supporting areas. Perform bioburden testing of water an in process samples to detect microorganisms and to obtain information on types and levels of microbial contamination. Perform Total Organic Carbon, Conductiv

Include ( but are not limited to ) Perform sampling of water and pure steam to support manufacturing activities. Perform Environmental Monitoring of isolator and supporting areas. Perform Compressed Air and Gas Sampling and Testing. Perform bioburden testing of water an in process samples to detect microorganisms and to obtain information on types and levels of microbial c

Include (but are not limited to) Manage day to day prioritization of routine, in process, stability, and finished product work. Supervises lab personnel, including staff performance and creation of staff schedules to ensure over time/weekend coverage for manufacturing support. Work with management to maintain working schedule of all work flowing through the QC Analytical L

Include (but are not limited to) Provide leadership to QC Microbiology Managers and senior personnel. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring. Ensure adequate QC support of GRAM operations across all shifts, including occasional weekend support. Develop and maintain resource plans addressing personnel, facility, an

Include (but are not limited to) Provide support to the manufacturing team when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling duties as needed. Oversee operations in cleanroom environment and communicate with supervision to devise appropriate resource delegation plans. Assist personnel on troubleshooting and

Include (but are not limited to) Coordinate and oversee process validation activities (PPQ). Prepare appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities. Conduct validation studies. Utilize risk assessment to identify critical areas for validation and generate test

Include (but are not limited to) Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation in support of GRAM and client driven projects including Standard Operating Procedures; Test Methods; Raw Material, Component, and Finished Product Specifications; Risk Assessments including cha

Include ( but are not limited to ) Conduct the identification and transfer of manufacturing processes from early stage development through transition to commercial manufacturing. Conduct the identification and transfer of finishing processes (Terminal Sterilization, Inspection, Labeling and Packaging) from engineering through commercial finishing. Conduct new equipment and

Include ( but are not limited to ) Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance. Establish and maintain good technique with regards to working in classified areas (including gowning qualification). Review and approve executed

Include (but are not limited to) Provide supervision to Quality Specialists of various levels. Responsibilities include managing, motivating, coaching and mentoring. Ensure Quality support and oversight of Aseptic Operations across all shifts, including weekend support. Oversight and management of the batch record review processes. Review and assessment of non conformance