Job Description SUMMARY Sr Associate Risk Management role will participate in the design, development, and execution of programs and initiatives supporting the risk management strategy of AML, which includes developing, executing, and potentially managing work plans, identifying data needs, gathering data (quantitative and qualitative), analyzing data, developing recommendations and creating presentations around recommendations. The prospective candidate will be responsible for supporting AML's Business Units in the identification, monitoring and mitigation of operational and quality risks in alignment with the overarching Risk Management and Business Continuity programs that aim uninterrupted supply to patients. SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Provides support to AML Inspection, Packaging and Solid Dosage business unit in the execution of the risk management program, including Quality, EH&S, Operations, and Business Continuity & Crisis Management requirements Participates as a core team member of the Site Risk Management team providing risk activity review, prioritization, and overall risk program support for the respective business unit Supports the development of the site risk management plan Provides guidance to Risk Owner(s) to determine how projects and/or process changes may impact the risk portfolio of the business unit Supports the development and execution of the risk management communication plan Builds technical expertise, and integration with other site processes to insure success, continuous improvement, and longevity of the RM program at the site Acquires and shares risk information from other AML business units, the network of Amgen sites, or external sources to implement lessons learned and best practices Advises risk owners on the risk assessment tools most suitable to meet risk program requirements Provides the site governance team with various portfolio analysis reports and updates that will allow understanding of overall risk level at the business unit, and therefore, the Site Ensures that people executing risk management activities are properly trained in accordance with governing procedures and risk program standards Ensures that Risk Assessment facilitators are entitled through training and qualification for performing respective risk assessments Supports facilitation of risk management activities (if required) Receives risk identification form and records and monitors the progress of all risks that enter the business unit risk portfolio. Reviews all submitted risk identification forms for accuracy Tracks all assessment work done and review it for accuracy and consistency Manages all record keeping required to maintain the risk portfolio Manages all reporting and documentation needed to support Risk Management governance Provides all administrative support required by the Risk Management Governance Team Meets with Risk Mitigation Owners regularly to monitor the status of all risks and actions defined in the portfolio for the business unit Ensures alignment of business unit activities with site risk management program, corporate policy, standards, and strategies Identifies and facilitates (as necessary) required risk assessments in business unit projects to ensure manage any impact to the risk profile of the business unit Provides subject matter expert support to the change control process as required by procedure Ensures business unit compliance with governing documents for Quality Risk Management BASIC EDUCATION & EXPERIENCE Master Degree OR Bachelor's degree and 2 years of experience in pharmaceutical, medical device and or biotechnology industry PREFERRED QUALIFICATIONS Educational background in Industrial Engineer Project Management, Risk Management, and EH&S experience desirable 3 years of relevant work experience with 1 year experience in Inspection, Packaging and/or Solid Dosage operations/manufacturing environment. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) preferred. Technical writing skills Good organizational skills, detail-oriented & accurate, analytical skills. Excellent communication skills (both written and verbal), facilitation, and presentation skills in Spanish and English Self-starter, highly motivated individual that can work under minimal supervision Team player that naturally complements with peers, clients and all levels of the organization. Works effectively with diverse departmental groups. Excellent interpersonal skills that can effectively communicate with peers, clients and all levels of the organization Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses
Ciudad: juncos
