Include (but are not limited to) Assist with the leading, planning, and implementation of customer projects. Act as a liaison between customers and team members. Seek opportunities to increase customer satisfaction and deepen customer relationships. Assist with the planning and definition of the project scope, milestones, risks, goals, and deliverables through implementati

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 ) 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) Act as internal CI consultant to all levels and Departments within the organization. Teach and coach individuals on Continuous Improvement Tools and Methodologies. Coach and mentor individuals on how to drive their own improvement initiatives by using continuous improvement tools and methodologies. Engage as a CI facilitator for improvement

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

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 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 ) 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) 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