Receiving Functions Verify incoming shipments against Bill of Ladings, and Purchase orders for correct items, counts and contents. Receive incoming inventory and commodities directly in the AS400 computer system or by the use of scanning guns. Put away received inventory items in proper storage locations. Deliver received non inventory materials to end user community. Seg

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform manufacturing and development activities within a cleanroom environment. Cleans and stores manufacturing equipment and areas as required to support manufacturing activities. Sanitization/disinfection of components, materials and p

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, and health and safety requirements. Manage assigned daily workload to meet requirements and perfor

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Lead deviation/investigation activities involving production batch records, and support release of product for shipment. Oversee Functional Areas and site QA investigations to ensure they are complete. Lead Investigator personnel and othe

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

This Medical Director, Pharmacovigilance position will directly report to the Senior Medical Director, Head of Pharmacovigilance. This position is responsible for the accurate and timely reporting of product safety information to the organization and regulatory authorities world wide as assigned by the Head of Pharmacovigilance. Provide medical support to the PV team for

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. 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

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for the implementation, maintenance, administration and communication of American Regent's health & welfare benefit plans, work life balance policies, and retirement program. Responsible for collaborating with leadership on th

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. Assist in continual improvements and facilitation for onboarding for onsite and offsite employees. Facilitation of Training Programs throughout the company including but limited to Data Integrity Trainings, Post Orientation, Professional

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