1+ months

Manager Quality Control: Weekend Shift

Amgen
West Greenwich, RI 02817
  • Job Code
    117210588
Amgen

Job ID: R-91496
Location: West Greenwich, RI, US 02817

Under minimal supervision, the Manager Quality Control will be responsible for activities including sample management, Microbiology Testing, Polymerase chain reaction (PCR) Testing, and Environmental Monitoring (EM) and Water Collection and Testing in a dynamic team environment ensuring business continuity on off shift: Saturday, Sunday and Monday 7am-7pm.
  • Responsible for leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks
  • Responsible for providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP) and other applicable regulations
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
  • Performs review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and Corrective Actions / Preventative Actions (CAPAs)
  • Supports Continual Improvement and LEAN initiatives, programs and projects
  • Ensures that changes that could potentially impact product quality are assessed according to procedures
  • Ensures that deviations from established procedures are investigated and documented per procedures
  • Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements
  • Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
  • Alerts senior management of quality, compliance, supply and safety risks
  • Represents the quality unit during audits and inspections
  • Supports internal/external audits and inspections as part of the audit/inspection management team


Basic Qualifications

Doctorate degree
OR
Master's degree and 3 years of Quality or Operations experience
OR
Bachelor's degree and 5 years of Quality or Operations experience
OR
Associate's degree and 10 years of Quality or Operations experience
OR
High school diploma / GED and 12 years of Quality or Operations experience
AND
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications
  • Strong knowledge and understanding of GMP pharmaceutical production and associated sampling handling requirements
  • Knowledge and experience with general GMP laboratory operations and associated equipment
  • Experience with computerized laboratory information management systems
  • Ability to lead diverse teams
  • Good communication skills (technical writing and verbal communication/presentation)
  • Ability to work in cross-functional and multi-site teams
  • Interact effectively with variety of communication and working styles
  • Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.


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.

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.

PI117210588

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91496<br/><b>Location: </b>West Greenwich, RI, US 02817<br/><br/>Under minimal supervision, the Manager Quality Control will be responsible for activities including sample management, Microbiology Testing, Polymerase chain reaction (PCR) Testing, and Environmental Monitoring (EM) and Water Collection and Testing in a dynamic team environment ensuring business continuity on off shift: Saturday, Sunday and Monday 7am-7pm.<br><ul><li>Responsible for leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks</li><li>Responsible for providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP) and other applicable regulations</li><li>Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations</li><li>Performs review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and Corrective Actions / Preventative Actions (CAPAs)</li><li>Supports Continual Improvement and LEAN initiatives, programs and projects</li><li>Ensures that changes that could potentially impact product quality are assessed according to procedures</li><li>Ensures that deviations from established procedures are investigated and documented per procedures</li><li>Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements</li><li>Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures</li><li>Alerts senior management of quality, compliance, supply and safety risks</li><li>Represents the quality unit during audits and inspections</li><li> Supports internal/external audits and inspections as part of the audit/inspection management team </li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree<br>OR<br>Master's degree and 3 years of Quality or Operations experience<br>OR<br>Bachelor's degree and 5 years of Quality or Operations experience<br>OR<br>Associate's degree and 10 years of Quality or Operations experience<br>OR<br>High school diploma / GED and 12 years of Quality or Operations experience<br>AND<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 knowledge and understanding of GMP pharmaceutical production and associated sampling handling requirements</li><li>Knowledge and experience with general GMP laboratory operations and associated equipment</li><li>Experience with computerized laboratory information management systems</li><li>Ability to lead diverse teams</li><li>Good communication skills (technical writing and verbal communication/presentation) </li><li>Ability to work in cross-functional and multi-site teams</li><li>Interact effectively with variety of communication and working styles</li><li>Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.</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>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/b7OjXqhPWxyrFxEkINmMp"> <p>PI117210588</p>

Categories

Posted: 2020-01-17 Expires: 2020-02-17

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manager Quality Control: Weekend Shift

Amgen
West Greenwich, RI 02817

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast