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 ) Accurately document data, complete batch records and execute documentation review as needed. Continually audit all personnel for compliance and use of proper aseptic technique. Support and enforce the departmental vision, goals and quality standards. Oversee operations in cleanroom environment. Communicate cross functionally to provide sc

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

Include ( but are not limited to ) Stock and maintain laboratory supplies. Monitor inventory levels and order or secure supplies as needed. Maintain laboratory environment in orderly, operable condition. Basic laboratory testing, sample and standard preparation, reagent preparation and maintenance, analysis. Use of appropriate respiratory equipment to complete assigned tas

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) Perform routine system administrator duties assigning licenses, granting user access levels, troubleshooting user login issues. Work with program managers and project managers to build and maintain effective workspaces used as project management tools. Create, maintain, and act as GRAM's Project Manager Training / Coordinator for project ma

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 technical support for HVAC and piping projects throughout GRAM, including assessing current building conditions, and determining appropriate recommended measures and designing and managing projects to address. Responsible for the building automation and management systems, along with most mechanical and qualified utilities systems s

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) Support quality systems including Regulatory Surveillance, Annual Product Reviews, Controlled Substance Program, customer complaints, internal audits, and external audits Supports work such as Performing internal and external audits per approved schedules; Support continuous improvement efforts by issuing audit observations in a clear and c

Include ( but are not limited to ) Provide supervision to Quality Specialists and Quality Technicians of various levels. Responsibilities include managing, motivating, coaching and mentoring. Ensure Quality support and oversight of Finishing operations across all shifts, including occasional weekend support. Oversight and management of the batch record review and final rel

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