14 days old

Sr. Associate QA, Incoming QA

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115164534
Amgen

Job ID: R-87080
Location: Thousand Oaks, CA, US 91360

The Sr Associate QA will be responsible for providing Plant Quality Assurance oversight within the GMP receiving, raw material inspection and raw material sampling areas as a member of the Incoming QA team. Under general supervision, this role will work closely with Planning, External Quality, the Quality Control (QC) laboratories, and Disposition QA to evaluate and release raw materials for clinical and commercial manufacturing according to demand and production timelines.

Responsibilities:
  • Execute raw material receipt, inspection, and sampling including completion of GMP documentation to support raw material disposition
  • SOP revision and/or approval
  • Work Order approval
  • Purposeful presence "on the shop floor"
  • Investigate, review, and approve Deviation investigations; manage corrective action plans to prevent issue recurrence.
  • Identify opportunities for continuous improvement and implement improvements in partnership with QA and Supply Chain/Manufacturing peers.
  • Ensure the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations.
  • Support internal and external audits of Incoming QA raw material processes and facilities.
  • Work within electronic signature quality systems supporting inventory management, document management, equipment management, deviation management, change control, etc.


Basic Qualifications:

Master's degree

OR

Bachelor's degree & 2 years of Quality or GMP Manufacturing experience

OR

Associate's degree & 6 years of Quality or GMP Manufacturing experience

OR

High school diploma / GED & 8 years of Quality or GMP Manufacturing experience

Preferred Qualifications:
  • Bachelor's Degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
  • Direct experience with raw material receipt, inspection, and sampling
  • Experience managing projects through to completion meeting timelines
  • Evaluating documentation and operations according to company procedures
  • Experience working with Quality Systems
  • Experience interacting with representatives of regulatory agencies
  • Strong organizational skills and ability to manage multiple tasks at one time
  • Effective communication skills (both written and verbal)
  • Demonstrated ability to work as both a team player and independently
  • Display leadership attributes and drive improvement initiatives.


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.

PI115164534

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87080<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Sr Associate QA will be responsible for providing Plant Quality Assurance oversight within the GMP receiving, raw material inspection and raw material sampling areas as a member of the Incoming QA team. Under general supervision, this role will work closely with Planning, External Quality, the Quality Control (QC) laboratories, and Disposition QA to evaluate and release raw materials for clinical and commercial manufacturing according to demand and production timelines.<br><br><b> Responsibilities: </b><br><ul><li>Execute raw material receipt, inspection, and sampling including completion of GMP documentation to support raw material disposition</li><li>SOP revision and/or approval</li><li>Work Order approval</li><li>Purposeful presence "on the shop floor"</li><li>Investigate, review, and approve Deviation investigations; manage corrective action plans to prevent issue recurrence.</li><li>Identify opportunities for continuous improvement and implement improvements in partnership with QA and Supply Chain/Manufacturing peers.</li><li>Ensure the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations.</li><li>Support internal and external audits of Incoming QA raw material processes and facilities.</li><li>Work within electronic signature quality systems supporting inventory management, document management, equipment management, deviation management, change control, etc.</li></ul><br><br><b>Basic Qualifications:</b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree & 2 years of Quality or GMP Manufacturing experience<br><br>OR<br><br>Associate's degree & 6 years of Quality or GMP Manufacturing experience<br><br>OR<br><br>High school diploma / GED & 8 years of Quality or GMP Manufacturing experience<br><br><b>Preferred Qualifications:</b><br><ul><li>Bachelor's Degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies</li><li>Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices</li><li>Direct experience with raw material receipt, inspection, and sampling</li><li>Experience managing projects through to completion meeting timelines</li><li>Evaluating documentation and operations according to company procedures</li><li>Experience working with Quality Systems</li><li>Experience interacting with representatives of regulatory agencies</li><li>Strong organizational skills and ability to manage multiple tasks at one time</li><li>Effective communication skills (both written and verbal)</li><li>Demonstrated ability to work as both a team player and independently</li><li>Display leadership attributes and drive improvement initiatives.</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/JBGBG1cpKL4EcPJVfXzVe"> <p>PI115164534</p>

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Posted: 2019-11-05 Expires: 2019-12-06

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Sr. Associate QA, Incoming QA

Amgen
Thousand Oaks, CA 91360

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