11 days old

Senior Associate Quality Control

Amgen
West Greenwich, RI 02817
  • Job Code
    115029942
Amgen

Job ID: R-87057
Location: Rhode Island, RI, US

Fast-paced quality laboratory is looking for a detail-oriented candidate with cell-based assay experience to join our bioassay and ELISA team.

Reporting to the Manager of Quality Control, the Bioassay/ELISA Quality Control Sr. Associate will support cGMP Bioassay method transfer, qualification and release testing for QC, drug substance and finished product testing for manufacturing and affiliated contract organizations. The individual will execute methods and review data for bioassay testing. This position will contribute to related method transfers and qualification activities.

Responsibilities :
  • Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
  • Operate and maintain specialized laboratory equipment and instrumentation
  • Participate in laboratory investigations and audits
  • Comply with safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
  • Ensure facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
  • Perform review and approval of procedures, assays, documents and records, including but not limited to Nonconformance records and CAPAs (Corrective Actions/Preventative Actions)
  • Support Continual Improvement initiatives, programs and projects
  • Alert management of quality, compliance, supply and safety risks
  • Support internal/external audits and inspections as needed
  • Complete required assigned training to permit execution of required tasks


Basic Qualifications

Master's Degree

OR

Bachelor's Degree and 2 years of Quality or Operations experience

OR

Associate's degree and 6 years of Quality or Operations experience

OR

High school diploma/GED and 8 years of Quality or Operations experience

Preferred Qualifications
  • Experience in performing cell based analytical methods such as ELISA (Enzyme-linked immunosorbent assay, bioassay and potency assays
  • Demonstrated experience in investigations, change control, validation, audits, Quality Control processes
  • Demonstrated ability to interpret scientific literature
  • Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
  • Strong communication skills (both written and oral), facilitation and presentation skills


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.

PI115029942

<strong>Amgen</strong><br /><br /><strong>Job ID: </strong>R-87057<br /><strong>Location: </strong>Rhode Island, RI, US<br /><br />Fast-paced quality laboratory is looking for a detail-oriented candidate with cell-based assay experience to join our bioassay and ELISA team.<br /><br />Reporting to the Manager of Quality Control, the Bioassay/ELISA Quality Control Sr. Associate will support cGMP Bioassay method transfer, qualification and release testing for QC, drug substance and finished product testing for manufacturing and affiliated contract organizations. The individual will execute methods and review data for bioassay testing. This position will contribute to related method transfers and qualification activities.<br /><br />Responsibilities :<br /> <ul> <li>Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks</li> <li>Operate and maintain specialized laboratory equipment and instrumentation</li> <li>Participate in laboratory investigations and audits</li> <li>Comply with safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements</li> <li>Ensure facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations</li> <li>Perform review and approval of procedures, assays, documents and records, including but not limited to Nonconformance records and CAPAs (Corrective Actions/Preventative Actions)</li> <li>Support Continual Improvement initiatives, programs and projects</li> <li>Alert management of quality, compliance, supply and safety risks</li> <li>Support internal/external audits and inspections as needed</li> <li>Complete required assigned training to permit execution of required tasks</li> </ul> <br /><br /><strong>Basic Qualifications </strong><br /><br />Master's Degree<br /><br />OR<br /><br />Bachelor's Degree and 2 years of Quality or Operations experience<br /><br />OR<br /><br />Associate's degree and 6 years of Quality or Operations experience<br /><br />OR<br /><br />High school diploma/GED and 8 years of Quality or Operations experience<br /><br /><strong>Preferred Qualifications </strong><br /> <ul> <li>Experience in performing cell based analytical methods such as ELISA (Enzyme-linked immunosorbent assay, bioassay and potency assays</li> <li>Demonstrated experience in investigations, change control, validation, audits, Quality Control processes</li> <li>Demonstrated ability to interpret scientific literature</li> <li>Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision</li> <li>Strong communication skills (both written and oral), facilitation and presentation skills</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/OaAnMlFEEGPkCDqdupBkx"> <p>PI115029942</p>

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Posted: 2019-11-01 Expires: 2019-12-02

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Senior Associate Quality Control

Amgen
West Greenwich, RI 02817

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