Amgen

Sr. Specialist Quality Complaints - Product Team Member

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 20, 2019
Ref
R-78499
Required Education
High School or equivalent
Position Type
Full time
The Sr. Specialist Quality Complaints - Product Team Member is accountable to determine regulatory escalation for critical complaint failures and any action which may be necessary to show due diligence with trends in root cause.

Key Responsibilities
  • Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance Amgen's products
  • Leads and participates on cross-functional product teams in analysis of the situation and the necessary steps to mitigate issues
  • Authors Annual Product Review (APR) / Post Market Surveillance (PMS) complaint sections
  • Interprets SOP and regulatory requirements
  • Sets project timelines and priorities
  • Integrates complaints data and information into plans, deliverables and clear GMP documentation
  • Partners with Amgen Safety and FPT to communicate potential Quality and Safety issues to Sites / Stakeholders
  • Ensures quality of complaint records
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Execution of regulatory and SOP requirements
  • Communication of complaint issues / data to sites / stakeholders

Basic Qualifications

Doctorate degree and 2 years of Quality and/or Manufacturing experience

OR

Master's degree and 6 years of Quality and/or Manufacturing experience

OR

Bachelor's degree and 8 years of Quality and/or Manufacturing experience

OR

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

OR

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

Preferred Qualifications
  • 8+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • Leadership skills and the ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience in 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)
  • Ability to travel +/- 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.