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. Plan daily workload to meet requirements. Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas. Conduct water sampling throughout facility. Record results and report devia

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Gathers, stages and returns production materials in support of manufacturing activities. Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing. Maintains cleanliness of manufacturing equi

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist PK/BE team in reviewing literature and summarizing important information . Learn and inform novel research methodologies in pharmacokinetics and bioequivalence studies. Assist PK BE team in organizing and maintaining project specif

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist PK/BE team in reviewing literature and summarizing important information . Learn and inform novel research methodologies in pharmacokinetics and bioequivalence studies. Assist PK BE team in organizing and maintaining project specif

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist in the collaboration with necessary business partners to develop CSV documentation required by ARI policy based on project assignments. Assist with the review of the department SOPs and validation documentation for GxP systems. Gat

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Obtain regulatory documents and initiate eCTD compilation using templates, publishing tools and publishing software. Prepare high quality regulatory submissions for multiple programs/products in development (e.g. IND, NDA, ANDA, and VMF)

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Manage Preventative Maintenance/Calibration/Repair Program Prepare, maintain, and follow procedures for the maintenance, calibration, and metrology systems and associated processes to adhere to cGMP's, company, local and state requirement

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

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. 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