This individual will be responsible for shift 2 and 3.
Shift 2 starts from 1 pm until 11 pm and Shift 3 starts from 10 pm until 8 am. New hire will work hours depending on need.
The Manager Quality Assurance will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner.
? Independently determine approach to managing daily operations; guided by general policies and management guidance ? Develop or contribute to the development of procedures and standards by which others will operate. ? Interpret and execute standards and procedures directly affecting work activities ? Develops and communicates goals and objectives to staff and key partners ? Monitor goal performance and coordinate action for improvement of shift and overall PQA performance by championing department OPEX efforts. Assist project teams in establishing priorities, project timelines and in securing resources. ? Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership ? Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change ? Reviewing and approving operational procedures and product manufacturing procedures, approving process validation protocols and reports for manufacturing processes, and approving environmental characterization reports and change control documents. ? Approving non-conformances, representing QA on project teams and approving change-over completion controls. ? Leading investigations, as well as leading plant and site audits.
? Doctorate degree ? OR ? Master's degree and 3 years of Quality experience ? OR ? Bachelor's degree or and 5 years of Quality experience ? OR ? Associate's degree and 10 years of Quality experience ? OR ? High school diploma / GED and 12 years of Quality experience ? AND ? 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
? Bachelor's Degree in Life Sciences, Engineering or related field ? 6 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry ? 3 + years of supervisory/management experience ? Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control ? Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment ? Ability to develop meaningful team and staff goals, manage performance and coach and develop staff ? Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives. ? Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations ? Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization ? Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs
Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing
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 on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.