12 days old

Senior Associate Quality Assurance

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116922733
Amgen

Job ID: R-91117
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior Associate Quality Assurance to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

This role will assume the responsibility for supporting Quality System related deliverables for the External Quality Organization in support of Amgen's network of Contract Manufacturers, Contract Labs and Suppliers. This individual will be working with cross-functional teams that includes members from Amgen Contract Manufacturing Operations, Supplier Quality Management, Process Development, and Supply Chain.

Responsible to train, manage and perform the following QMS related activities for External Quality Suppliers & Contractors:
  • Own Quality records (Supplier Change Notifications, Change controls and deviations), manage and drive records to closure independently
  • Ensure the record is documented in in GMP system completely per applicable SOPs.
  • Understand and interpret of applicable GMP Regulations pertaining to the Quality systems or processes
  • Perform LIMs data entry and other data entry related tasks
  • Perform data verification of documents
  • Provide support for External Quality Systems and processes
  • Lead or participate on Quality System improvement projects
  • Own and revise procedures
  • Support metrics gathering
  • Support the process of periodic monitoring of external suppliers
  • Tracking and facilitation of the closure of External Supplier commitments


Work cross functionally with ACM organization to execute to day-to-day responsibilities within QMS related systems. Support key deliverables and/ or projects as part of External Quality. Assure progress against commitments to regulatory agencies, identify compliance gaps and update all relevant procedures

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:
  • 2 plus years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Able to facilitate and influence team members clients and partners
  • Strong project management, problem-solving, and analytical skills; experience with project management tools
  • Able to successfully manage workload to timelines
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Understanding of both Quality Systems and industry requirements/expectations of a NC, CAPA, Complaints and Change Control
  • Experience in Root Cause Analysis, as applicable to role
  • Familiarity of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, Supplier Quality Management)
  • Experience driving timely decision making
  • Demonstrated experience with Quality Systems, such as NC, CAPA, complaints and/or Change Control 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 provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.



    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.

    PI116922733

    <b>Amgen</b><br/><br/><b>Job ID: </b>R-91117<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Senior Associate Quality Assurance to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: <br><br>This role will assume the responsibility for supporting Quality System related deliverables for the External Quality Organization in support of Amgen's network of Contract Manufacturers, Contract Labs and Suppliers. This individual will be working with cross-functional teams that includes members from Amgen Contract Manufacturing Operations, Supplier Quality Management, Process Development, and Supply Chain.<br><br>Responsible to train, manage and perform the following QMS related activities for External Quality Suppliers & Contractors:<br><ul><li>Own Quality records (Supplier Change Notifications, Change controls and deviations), manage and drive records to closure independently</li><li>Ensure the record is documented in in GMP system completely per applicable SOPs.</li><li>Understand and interpret of applicable GMP Regulations pertaining to the Quality systems or processes</li><li>Perform LIMs data entry and other data entry related tasks</li><li>Perform data verification of documents</li><li>Provide support for External Quality Systems and processes</li><li>Lead or participate on Quality System improvement projects</li><li>Own and revise procedures</li><li>Support metrics gathering</li><li>Support the process of periodic monitoring of external suppliers</li><li>Tracking and facilitation of the closure of External Supplier commitments</li></ul><br><br>Work cross functionally with ACM organization to execute to day-to-day responsibilities within QMS related systems. Support key deliverables and/ or projects as part of External Quality. Assure progress against commitments to regulatory agencies, identify compliance gaps and update all relevant procedures<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>2 plus years of quality and manufacturing experience in biotech or pharmaceutical industry</li><li>Able to facilitate and influence team members clients and partners</li><li>Strong project management, problem-solving, and analytical skills; experience with project management tools</li><li>Able to successfully manage workload to timelines</li><li>Ability to negotiate a strategic position after taking feedback from multiple sources</li><li>Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results</li><li>Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution</li><li>Ability to operate in a matrixed or team environment with site, functional, and executive leadership</li><li>Understanding of both Quality Systems and industry requirements/expectations of a NC, CAPA, Complaints and Change Control</li><li>Experience in Root Cause Analysis, as applicable to role</li><li>Familiarity of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, Supplier Quality Management)</li><li>Experience driving timely decision making</li><li>Demonstrated experience with Quality Systems, such as NC, CAPA, complaints and/or Change Control processes</li></ul><br><br><b>Amgen </b>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><b>Amgen</b> 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 </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <br><br><ul></ul><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/PdngE7co8OVkUMNmTPXLW"> <p>PI116922733</p>

    Categories

    Posted: 2020-01-08 Expires: 2020-02-08

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    Senior Associate Quality Assurance

    Amgen
    Thousand Oaks, CA 91360

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