7 days old

Sr Associate Quality Complaints

Amgen
Cambridge, MA 02138
  • Job Code
    119286403
Amgen

Job ID: R-96844
Location: Cambridge, MA, US 02139

Amgen is seeking a Quality Complaints Sr. Associate to triage all complaints and own L1 Records, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management systems, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation.

The Sr. Associate Quality Complaints will be responsible for triaging complaints and managing L1 records for 1st Shift (Sunday through Thursday or Tuesday through Sunday 8am - 5pm).

Key Responsibilities:
  • Triage product complaint records
  • Ensures quality of complaint records
  • Applies analytical skills to evaluate complex situations using multiple sources of information
  • Executes SOP requirements
  • Develops solutions to technical problems of moderate complexity
  • Screens, evaluates, reports and resolves record integrity issues
  • Must be able to work off-shift


Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Quality experience

OR

Associate's degree and 6 years of Quality experience

OR

High school diploma / GED and 8 years of Quality experience

Preferred Qualifications
  • Quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • 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)


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.

PI119286403

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96844<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a Quality Complaints Sr. Associate to triage all complaints and own L1 Records, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management systems, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.<br><br>The Sr. Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation.<br><br>The Sr. Associate Quality Complaints will be responsible for triaging complaints and managing L1 records for <b>1st Shift</b> (Sunday through Thursday or Tuesday through Sunday 8am - 5pm). <br><br><b> Key Responsibilities: </b><br><ul><li>Triage product complaint records</li><li>Ensures quality of complaint records</li><li>Applies analytical skills to evaluate complex situations using multiple sources of information</li><li>Executes SOP requirements</li><li>Develops solutions to technical problems of moderate complexity</li><li>Screens, evaluates, reports and resolves record integrity issues</li><li>Must be able to work off-shift</li></ul><br><br><b>Basic Qualifications </b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of Quality experience<br><br>OR<br><br>Associate's degree and 6 years of Quality experience<br><br>OR<br><br>High school diploma / GED and 8 years of Quality experience<br><br><b>Preferred Qualifications </b><br><ul><li>Quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Bachelor's Degree in a Science Field</li><li>Ability to successfully manage workload to timelines</li><li>Familiarity with basic project management tools</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>Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)</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/g25Koas5rwXJUxaAIlr4k"> <p>PI119286403</p>

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Posted: 2020-03-24 Expires: 2020-04-24

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Sr Associate Quality Complaints

Amgen
Cambridge, MA 02138

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