27 days old

Quality Complaints Professional

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114880049
Amgen

Job ID: R-86031
Location: Thousand Oaks, CA, US 91360

The Specialist Quality Complaints is accountable to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine the steps necessary to ensure the proper level of control for product in distribution. May supervise a workgroup of complaint investigators which drives compliant documentation of customer complaints for a set of products.

Key Responsibilities
  • Ensures quality of complaint records
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Provides dedicated audit and inspection readiness and support
  • Conducts analysis related to inquiries from health authorities and summarizes key findings, driving to resolution
  • Conducts root cause analysis of product complaint intake issues and provides insights on the appropriate manner to prevent them in the future
  • Executes regulatory and SOP requirements
  • Anticipates and prevents potential issues with regulators
  • Provides expert guidance and technical advice
  • Evaluates subject matter expert assessments and provides direct feedback
  • Determines situations which require escalation of quality issues to management
  • Proposes revisions to SOPs in area of responsibility
  • As applicable, may provide staff member supervision, lead team's performance and development, and be responsible for financial oversight / team's budget management


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

  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • Knowledge of industry regulations
  • Six sigma certification and/or working knowledge
  • 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 consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Experience in driving decision making
  • 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.

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.

PI114880049

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86031<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Specialist Quality Complaints is accountable to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine the steps necessary to ensure the proper level of control for product in distribution. May supervise a workgroup of complaint investigators which drives compliant documentation of customer complaints for a set of products.<br><br><b> Key Responsibilities </b><br><ul><li>Ensures quality of complaint records</li><li>Applies analytical skills to evaluate complex situations using multiple sources of information </li><li>Provides dedicated audit and inspection readiness and support</li><li>Conducts analysis related to inquiries from health authorities and summarizes key findings, driving to resolution</li><li>Conducts root cause analysis of product complaint intake issues and provides insights on the appropriate manner to prevent them in the future</li><li>Executes regulatory and SOP requirements</li><li>Anticipates and prevents potential issues with regulators</li><li>Provides expert guidance and technical advice</li><li>Evaluates subject matter expert assessments and provides direct feedback</li><li>Determines situations which require escalation of quality issues to management</li><li>Proposes revisions to SOPs in area of responsibility</li><li>As applicable, may provide staff member supervision, lead team's performance and development, and be responsible for financial oversight / team's budget management</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Quality experience<br><br>OR<br><br>Bachelor's degree and 5 years of Quality experience<br><br>OR<br><br>Associate's degree and 10 years of Quality experience<br><br>OR<br><br>High school diploma / GED and 12 years of Quality experience<br><br><b>Preferred Qualifications </b><br><br><ul><li>4+ years of quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Bachelor's Degree in a Science Field</li><li>Knowledge of industry regulations</li><li>Six sigma certification and/or working knowledge</li><li>Ability to oversee multiple projects simultaneously</li><li>Ability to successfully manage workload to timelines</li><li>Familiarity with basic project management tools</li><li>Ability to negotiate a position after taking feedback from multiple sources</li><li>Demonstrated ability to consistently deliver on-time, and high-quality results</li><li>Ability to operate in a matrixed or team environment</li><li>Experience in driving decision making</li><li>Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)</li><li>Ability to travel +/- 10% of time to domestic and international Amgen sites</li></ul><br><br>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.<br><br>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.<br><br><b> 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. </b><br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/m6r1YnFbP6qAUKlqs4m2Z"> <p>PI114880049</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Quality Complaints Professional

Amgen
Thousand Oaks, CA 91360

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