13 days old

Manager Quality Control - Environmental Monitoring Lab

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117942508
Amgen

Job ID: R-91464
Location: Thousand Oaks, CA, US 91360

The Manager Quality Control will be responsible for supervision of all technical and operational activities within the QC Environmental Monitoring Lab at Amgen, Thousand Oaks. The Environmental Monitoring Lab is responsible for supporting routine environmental and utility monitoring as well as gowning sampling in support of manufacturing operations.

Responsibilities:
  • Leads, coaches and develops a team of Environmental Monitoring Lab staff
  • Provides Environmental Monitoring expertise/guidance to lab staff and within cross-functional Amgen teams
  • Manages Environmental Monitoring Lab operations, which includes planning and execution of daily activities in accordance with the Environmental Monitoring program schedule and manufacturing needs
  • Owns and reviews controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Environmental Monitoring Lab activities
  • Ensures that the Environmental Monitoring Lab operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and laboratory controls
  • Represents the Environmental Monitoring Lab during Amgen internal/external audits and inspections. Direct interaction with regulatory agencies during on-site inspections.
  • Provides oversight of Environmental Monitoring Lab Quality Systems records including Deviations, CAPAs and Change Controls


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Quality Control/Quality Assurance experience

OR

Bachelor's degree and 5 years of Quality Control/Quality Assurance experience

OR

Associate's degree and 10 years of Quality Control/Quality Assurance experience

OR

High school diploma / GED and 12 years of Quality Control/Quality Assurance experience

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
  • Strong Quality background/experience
  • Experience applying problem-solving tools for root cause analysis
  • Experience with driving productivity and efficiency improvements. Familiarity with Lean concepts.
  • Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting
  • Demonstrated ability to develop, coach and mentor employees
  • Strong decision-making and negotiation skills
  • Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment


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.

PI117942508

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91464<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Manager Quality Control will be responsible for supervision of all technical and operational activities within the QC Environmental Monitoring Lab at Amgen, Thousand Oaks. The Environmental Monitoring Lab is responsible for supporting routine environmental and utility monitoring as well as gowning sampling in support of manufacturing operations.<br><br>Responsibilities:<br><ul><li>Leads, coaches and develops a team of Environmental Monitoring Lab staff</li><li>Provides Environmental Monitoring expertise/guidance to lab staff and within cross-functional Amgen teams</li><li>Manages Environmental Monitoring Lab operations, which includes planning and execution of daily activities in accordance with the Environmental Monitoring program schedule and manufacturing needs</li><li>Owns and reviews controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Environmental Monitoring Lab activities</li><li>Ensures that the Environmental Monitoring Lab operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and laboratory controls</li><li>Represents the Environmental Monitoring Lab during Amgen internal/external audits and inspections. Direct interaction with regulatory agencies during on-site inspections.</li><li>Provides oversight of Environmental Monitoring Lab Quality Systems records including Deviations, CAPAs and Change Controls</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Quality Control/Quality Assurance experience<br><br>OR<br><br>Bachelor's degree and 5 years of Quality Control/Quality Assurance experience<br><br>OR<br><br>Associate's degree and 10 years of Quality Control/Quality Assurance experience<br><br>OR<br><br>High school diploma / GED and 12 years of Quality Control/Quality Assurance experience<br><br>AND<br><br>Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Preferred Qualifications </b><br><ul><li>Strong Quality background/experience</li><li>Experience applying problem-solving tools for root cause analysis</li><li>Experience with driving productivity and efficiency improvements. Familiarity with Lean concepts.</li><li>Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting</li><li>Demonstrated ability to develop, coach and mentor employees</li><li>Strong decision-making and negotiation skills</li><li>Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment</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/Pdn7W4To6PoPiMNmTPXLW"> <p>PI117942508</p>

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Posted: 2020-02-11 Expires: 2020-03-13

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Manager Quality Control - Environmental Monitoring Lab

Amgen
Thousand Oaks, CA 91360

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