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 ) Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed. Accurately document data and complete batch records as needed. Perform cleaning and sanitization duties as instructed by the applicable procedure. Successfully complete facility's aseptic gowning and manufacturing qualification program. Perform dut

Include ( but are not limited to ) Issue, maintain, and reconcile controlled documents, including logbooks, controlled copies, execution copies, controlled forms. Coordinate archival (and retrieval, electronic searching, etc.) of GMP documents with offsite records management vendor, boxing, organizing, and shipping records at regular intervals. Execute reports in the docum

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

Include (but are not limited to) Develop and carry out successful sourcing and recruiting strategies to meet people needs. Facilitate the pre employment process and provide assistance to hiring managers in candidate interviewing/selection. Work within HRIS system to maintain accurate candidate records. Work with hiring managers to understand roles and desired traits of qua

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 ) 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) 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