Amgen

Sr. Quality Engineer- Commercial Quality

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 29, 2019
Ref
R-82649
Required Education
High School or equivalent
Position Type
Full time
The Sr Quality Engineer - Commercial Quality is accountable for providing quality oversight of final product activities, ensuring that Quality Systems that are identified for commercial sustainment and life cycle management of commercially available final product, including devices and combination products are appropriate and compliant. The Senior Quality Engineer manages low to moderate complexity programs and provide input on proper quality resource balancing on project(s) as required.

This position reports to the Director Commercial Quality, FPTQ and is an advisor to Development Quality Lead in FPTQ, advisor to Core Technologies Quality Lead and advisor to Medical Information regarding instructional material interfaces with end user.

Key Responsibilities:
  • Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for Final Product Technologies commercial activities.
  • Attend commercial program meetings as required as part of program working teams.
  • Work cross-functionally with individuals and project teams to ensure success of commercial project efforts.
  • Provide guidance on documentation structures created during lifecycle management activities.
  • Identify proper GMP documentation strategies and repositories required to ensure compliance with applicable regulations and Amgen Procedures.
  • Provide input to change controls for projects, and review and approve relevant Design Control documentation.
  • Maintain Traceability Matrix and provide review and approval for subordinate project plans and associated projects and contribute to applicable Design Control Phase Design Reviews.
  • Provide Quality oversight of Design Characterization, Verification and Validation activities as required through change control and/or CAPA for life cycle management of commercial programs.
  • Ensure adherence to all relevant commercial final product regulations and standards.
  • Represent and participate in onsite supplier due diligence visits, as needed, in support of supplier investigations and qualification activities.
  • Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of commercial programs.
  • Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
  • Projects may include secondary packaging, primary container, mechanical, electrical, and/or software as part of the system(s).
  • Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and
  • Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs.
  • Participates in deviation, CAPA, & Complaint investigations for commercial programs.
  • Ability to travel +/- 15-20% of time to domestic and international Amgen sites


Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Quality experience

OR

Bachelor's Degree 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.

Preferred Qualifications:
  • 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
  • Bachelor's Degree in a Science Field
  • Ability to oversee multiple medium complexity projects simultaneously
  • Working knowledge of quality engineering and/or mechanical engineering
  • Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
  • Prior experience working as part of a combination product launch team
  • Able to successfully manage workload to timelines
  • Ability to effectively negotiate a position after taking feedback from multiple sources
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience driving decision making by using DAI principles
  • Understanding of industry requirements/expectations of a QMS
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations
  • Comfortable with both drug and device terminology


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.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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.