26 days old

Specialist Quality Control - Environmental Monitoring

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118664023
Amgen

Job ID: R-94029
Location: Thousand Oaks, CA, US 91360

The Specialist Quality Control will support the Environmental Monitoring Lab at Amgen Thousand Oaks. The EM Lab provides environmental monitoring sampling and gowning certification support for the manufacturing and manufacturing support areas at Amgen's Thousand Oaks site.

Responsibilities:
  • Primary owner for deviation and change control records within the EM Lab
  • Responsible for evaluating and on-boarding new environmental monitoring equipment within the EM Lab and across ATO site
  • Provide back-up support for the ATO site Environmental Monitoring Program Owner: reviewing environmental monitoring data and trend reports, provide EM subject matter expertise within QC and across ATO site, generation of EM Lab metrics and represent the EM program/EM Lab during audits and inspections
  • Environmental Monitoring raw data review and approval
  • Assist the EM Lab Manager with scheduling and coordination of lab staff
  • Collecting surface, air viable and particulate environmental monitoring samples
  • Aseptic gowning and collection of gowning monitoring samples
  • Operation and maintenance of specialized equipment for sample collection
  • Ownership and revision of EM Lab controlled documents such as analytical methods and SOPs
  • Responsible for representing the EM Lab at QC internal and cross-functional meetings

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality or Manufacturing/Manufacturing support experience

OR

Bachelor's degree and 5 years of Quality or Manufacturing/Manufacturing support experience

OR

Associate's degree and 10 years of Quality or Manufacturing/Manufacturing support experience

OR

High school diploma / GED and 12 years of Quality or Manufacturing/Manufacturing support experience

Preferred Qualifications
  • Demonstrated leadership skills and capable of independently resolving issues
  • Excellent written and verbal communication skills
  • Experience with deviation and/or change control ownership
  • Previous experience working in a GMP Lab or manufacturing environment
  • Experience with working in a fast-paced and dynamic work environment
  • Experience with coordinating teams to deliver on business needs
  • Previous gowning experience
  • Understanding of the basic principles of Microbiology


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.

PI118664023

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94029<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Specialist Quality Control will support the Environmental Monitoring Lab at Amgen Thousand Oaks. The EM Lab provides environmental monitoring sampling and gowning certification support for the manufacturing and manufacturing support areas at Amgen's Thousand Oaks site.<br><br>Responsibilities:<br><ul><li>Primary owner for deviation and change control records within the EM Lab</li><li>Responsible for evaluating and on-boarding new environmental monitoring equipment within the EM Lab and across ATO site</li><li>Provide back-up support for the ATO site Environmental Monitoring Program Owner: reviewing environmental monitoring data and trend reports, provide EM subject matter expertise within QC and across ATO site, generation of EM Lab metrics and represent the EM program/EM Lab during audits and inspections</li><li>Environmental Monitoring raw data review and approval</li><li>Assist the EM Lab Manager with scheduling and coordination of lab staff</li><li>Collecting surface, air viable and particulate environmental monitoring samples</li><li>Aseptic gowning and collection of gowning monitoring samples</li><li>Operation and maintenance of specialized equipment for sample collection</li><li>Ownership and revision of EM Lab controlled documents such as analytical methods and SOPs</li><li>Responsible for representing the EM Lab at QC internal and cross-functional meetings</li><li></li></ul><br><b>Basic Qualifications </b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Quality or Manufacturing/Manufacturing support experience<br><br>OR<br><br>Bachelor's degree and 5 years of Quality or Manufacturing/Manufacturing support experience<br><br>OR<br><br>Associate's degree and 10 years of Quality or Manufacturing/Manufacturing support experience<br><br>OR<br><br>High school diploma / GED and 12 years of Quality or Manufacturing/Manufacturing support experience<br><br><b>Preferred Qualifications </b><br><ul><li> Demonstrated leadership skills and capable of independently resolving issues </li><li> Excellent written and verbal communication skills </li><li> Experience with deviation and/or change control ownership </li><li> Previous experience working in a GMP Lab or manufacturing environment </li><li>Experience with working in a fast-paced and dynamic work environment</li><li>Experience with coordinating teams to deliver on business needs</li><li>Previous gowning experience</li><li>Understanding of the basic principles of Microbiology</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/ygE7kwf6rwW2FkAdFGNVO"> <p>PI118664023</p>

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

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Specialist Quality Control - Environmental Monitoring

Amgen
Thousand Oaks, CA 91360

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