Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform Calibrations Follow written calibration procedures. Accurately complete calibration paperwork, including work orders and logbooks in accordance with existing company policies, procedures, and Current Good Manufacturing Practices,

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

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 equ

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Builds and develops enduring trusted partnerships through scientific engagement and exchange with KOL's and health care providers (HCPs) at the national, regional and local level Regularly collects and interprets medical insights and feed

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. 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. 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