All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134) Drug product inspection. Achieve and maintain Aseptic Processing Area (APA) gown qualification. Adhere to all SOP related to working in an aseptic environment, including volume/weight checks of product filled in vials and ampoules; s well as the monitoring of personnel Aseptic T

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Plan daily workload to meet requirements. Conduct environmental monitoring activities including air (Viable and Non viable), surface and personnel inside the sterile manufacturing areas. Conduct water sampling throughout facility. Perform

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Plan daily workload to meet requirements. Conduct environmental monitoring activities including air (Viable and Non viable), surface and personnel inside the sterile manufacturing areas. Conduct water sampling throughout facility. Perform

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in c

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Lead the development, optimization and validation activities of analytical methods for multiple projects simultaneously. Analyze and review project data and report for multiple projects in support of research and development for small mol

Duties Collaborate with IT to gather infrastructure and architectural requirements pertaining to relevant projects; Manage all project and compliance related issues associated with their project; May support, coordinate and interface with regulatory agencies as required in support of regulatory agency inspections; Support and maintain Quality programs, policies, processes

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor. Maintains accurate and complete records. Maintains an accurate and complete Training Record. Abi

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Lead the process development of pharmaceutical drug product and oversee manufacturing activities within a cleanroom environment. Plan and prepare process equipment skid setup for manufacturing processes. Exercise critical thinking in inve

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Stocks, gathers and stages manufacturing supplies and equipment. Gathers, stages and returns production materials as required to support manufacturing activities. Cleans and stores manufacturing equipment and areas as required to support

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Undertake and successfully complete projects including any of the following create/update SOPs and P&IDs, develop URS and purchase documents for a capital investment, equipment capability analysis, spare part or size change part organizat

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Stocks, gathers and stages manufacturing supplies and equipment. Gathers, stages and returns production materials as required to support manufacturing activities. Cleans and stores manufacturing equipment and areas as required to support

The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packagi

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health, and safety requirements. Plan daily workload to meet requirements. Draft Raw Material, In

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor. Performs a variety of production prep activities including deboxing, staging, equipment and component sterilizatio

Duties Coordinate Chemistry Laboratory testing to ensure that all required samples (raw materials, in process, and finished products) are received and tested. Monitor laboratory activities and achieve a smooth and timely operation. Conduct quality control tests. Communicate and give guidance to chemists and technicians where required. Maintain an adequate supply of invent