13 days old

Senior Associate QA - Drug Substance Manufacturing

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114997141
Amgen

Job ID: R-86896
Location: Thousand Oaks, CA, US 91360

The Senior Associate QA role supports Amgen's Quality Assurance program, providing daily oversight ofDrug Substance manufacturing facilities at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems. Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

This staff member will be assigned to provide quality support during either day or night shift schedule periods.

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

  • Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
  • Experience managing projects through to completion meeting timelines
  • Evaluating documentation and operations according to company procedures
  • Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk
  • Experience working with Quality Systems


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.

PI114997141

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86896<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Senior Associate QA role supports Amgen's Quality Assurance program, providing daily oversight ofDrug Substance manufacturing facilities at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems. Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.<br><br>This staff member will be assigned to provide quality support during either day or night shift schedule periods.<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><br><ul><li>Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.</li><li>Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.</li><li>Experience managing projects through to completion meeting timelines</li><li>Evaluating documentation and operations according to company procedures</li><li>Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk</li><li>Experience working with Quality Systems</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/BXBB4qSXKmYOHpB2iRrwl"> <p>PI114997141</p>

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Posted: 2019-10-31 Expires: 2019-12-01

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Senior Associate QA - Drug Substance Manufacturing

Amgen
Thousand Oaks, CA 91360

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