Specialist QA

Rhode Island, RI, US
Aug 09, 2019
Required Education
High School or equivalent
Position Type
Full time

  • Leading investigations, projects.
  • Leading and representation site audits where needed.
  • 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 QI 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 relevant documents, procedures, records.
  • Approving deviations, representing QI on project teams
  • Communication of Quality System status to Sr. Leadership in multiple forums; maintaining the metric reporting for site performance.

Note: Other responsibilities, accountabilities or decision authorities may be assigned

Basic Qualifications
  • Doctorate degree and 2 years Quality experience
  • OR
  • Master's degree and 6 years of Quality experience
  • OR
  • Bachelor's degree or and 8 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
  • At least 2 years of leadership experience leading teams, projects, programs

Preferred Qualifications
  • Bachelor's Degree in Life Sciences, Engineering or related field
  • 8 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
  • 5 + years of project 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 manage to establish 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, both written and oral, 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

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.