Amgen

External Supply Quality Specialist QA

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 16, 2019
Ref
R-80014
Required Education
High School or equivalent
Position Type
Full time
The External Supply Quality Specialist supports Quality System improvements, projects, and the External Quality SME team. This role will implement improvement projects that will improve our Quality Systems or Processes (transactional activities, training, and project management).

Key Responsibilities:
  • Identifying and resolve key issues, needs, constraints of the External Quality/Supply organization and drive Continuous Improvement solutions for resolution.
  • Provide Project Management support for the implementation of Quality System improvement projects and ensure teams remain on target with key milestone due dates.
  • Understanding and the ability to interpret applicable GMP Regulations pertaining to Quality Systems or Processes.
  • May act as a system SME (Subject Matter Expert) representing External Supply with the QMS network.
  • Communicate and ensure alignment on priority decisions.
  • Support External Supply staff to resolve Quality System questions or issues.
  • Provide tactical information to the networks (i.e., metrics to Management Review, data analysis, trending, Annual Product Review).
  • Perform ownership and Quality Assurance support of Quality System records.
  • Perform SAP data entry.
  • Support audits of internal Systems and Processes.
  • Drive timely decision-making using Decision making principles (DIA).
  • Drive Lean continuous improvements and Amgen first mindset.


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality or Manufacturing Experience

OR

Bachelor's degree and 5 years of Quality or Manufacturing Experience

OR

Associate's degree and 10 years of Quality or Manufacturing Experience

OR

High school diploma / GED and 12 years of Quality or Manufacturing Experience

Preferred Qualifications

  • 4+ years of quality and/or manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • cGMP Experience
  • Ability to oversee multiple projects simultaneously
  • Able to successfully manage workload to timelines
  • Familiarity with statistical analysis and basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel up to 10% of time to domestic and international Amgen sites


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.

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.