27 días de edad

Specialist Quality Control

Amgen
Thousand Oaks, CA 91360
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  • código de trabajo
    120013988
Amgen

Job ID: R-98929
Location: Thousand Oaks, CA, US 91360

The QC Specialist will be responsible for ownership and management of Deviation, CAPA and Change Control records for the Quality Control Laboratories at Amgen, Thousand Oaks. The Specialist will be responsible for end-to-end management of the record types listed above while ensuring that compliance requirements and business needs are met. Core to the responsibilities listed above will be the Specialist's ability to manage record timelines, lead teams, cultivate cross-functional relationships and implement effective solutions.

Responsibilities:
  • Coordinating and leading cross-functional investigation teams through the Deviation, CAPA and Root Cause Analysis process while adhering to Amgen program requirements
  • Ensuring proper documentation of Deviations, CAPAs and Change Controls in Amgen's enterprise Quality Management Tracking System
  • Identifying and implementing effective Corrective and Preventive Actions
  • Developing the strategic framework for Change Control record proposals; gathering and documenting the appropriate assessments to facilitate the change.
  • Representing Quality Control at Amgen internal Deviation, CAPA and Change Control review boards
  • Mentoring staff on the Deviation, CAPA and Change Control program requirements and process
  • Presenting Deviation, CAPA and Change Control records during internal and external audits
  • Identification of continuous improvement opportunities to ensure a productive work environment


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality or GMP Manufacturing/Manufacturing support experience

OR

Bachelor's degree and 5 years of Quality or GMP Manufacturing/Manufacturing support experience

OR

Associate's degree and 10 years of Quality or GMP Manufacturing/Manufacturing support experience

OR

High school diploma / GED and 12 years of Quality or GMP Manufacturing/Manufacturing support experience

Preferred Qualifications
  • Demonstrated leadership skills and the ability to influence others
  • Ability to work effectively with different functions, levels within the organization and with external partners
  • Experience participating in audits and interacting directly with inspectors
  • Experience with executing different root cause analysis methodologies
  • Previous experience with Deviation and/or Change Control ownership
  • Previous experience working in a GMP environment
  • Experience with coordinating teams to deliver on business needs
  • Analytical testing background or experience
  • Excellent technical writing skills
  • Strong time management and project management skills
  • Strong compliance background


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.



PI120013988

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Posted: 2020-05-01 Expires: 2020-06-01

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Specialist Quality Control

Amgen
Thousand Oaks, CA 91360

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