Amgen

Specialist QA

Employer
Amgen
Location
Rhode Island, RI, US
Posted
Jul 12, 2019
Ref
R-79934
Required Education
High School or equivalent
Position Type
Full time
Responsibilities:

  • 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