Include (but are not limited to) Provide leadership and guidance to the analytical services team. Assist in hiring, managing, motivating, coaching, and mentoring analytical scientists. Review and approve analytical documentation and procedures including material specifications, test methods, validation protocols, reports, standard operating procedures, and client work orde

Include (but are not limited to) Maintain and provide oversight of the execution for programs covering equipment and processes related to sterility assurance. Utilize risk assessment to identify critical areas for validation and determine testing approach. Review change control documents, work orders, and document change requests to assess impact on validated systems. Lead

Include (but are not limited to) Exhibit Complex Conflict resolution and problem solving skills in a cross functional setting. Work closely with respective team members from Operations, Engineering, Maintenance, Project Management and Quality to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of deviation investigat

Include (but are not limited to) Perform physical, chemical, and instrumental analysis of active pharmaceutical ingredients, excipients, in process samples, finished pharmaceutical products and stability. Run instrumentation independently, including but not limited to, HPLC, GC, FTIR, UV VIS and physical testing on pharmaceutical products according to client/compendia proc

Include (but are not limited to) Train Quality Control Chemists in new or revised test methods/procedures. Work cross functionally to transfer projects into the QC Analytical lab. Qualify new laboratory equipment. Work to author and execute CAPAs and Change Controls. Perform data review for accuracy, clarity, and adherence to GMP and/or GLP regulations. Full job descriptio

Include ( but are not limited to ) Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations. Review executed batch records and other associated controlled documents. Perform clearances and start up activities associated with Finishing Operations and Weigh and Dispense Booth operation. Perform QA rev

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) 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 ) 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