1+ months

Specialist QA

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    118538433
Amgen

Job ID: R-94329
Location: Juncos, PR, US 00777

Summary:

The QA Specialist position provides Quality oversight of Amgen's Global Supply Chain operations with specific emphasis on daily support of North American Hub operations in AML.

Under general supervision, the role provides support and compliance oversight to Global Supply Hub (GSH) staff in the execution of their processes, procedures, and use of quality systems. Daily duties include purposeful presence and face to face partnership with GSH staff and quality co-workers within the GSH work area or remotely when necessary. A successful candidate will demonstrate an ability to provide robust Quality Advice with specific skills in interpretation and application of Good Distribution Practices. Additional responsibilities will include the following:
  • Provides Quality Oversight of daily GSH through face to face partnership, as needed
  • Performs Transportation Lane review and approval
  • Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations
  • Provides quality expertise, with specific emphasis on Good Distribution Practices knowledge, and mentorship to operational staff within GSH
  • Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports
  • Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, Safety, and Controls.
  • Participates in Amgen internal/external audits and inspections. May directly work well with regulatory agencies during on-site inspections
  • Actively participate in continuous improvement initiatives and projects as necessary


The Senior Manager Quality Assurance (QA) will direct a team of QA professionals and provide Quality Management System (QMS) process subject matter expertise for International and Distribution Quality (IDQ)

The Senior Manager's team will provide Quality oversight in support Global Supply Chain (GSC) operations and include daily oversight of Global Supply Hub operations.

In addition, the Senior Manager's team will provide QA contact role for Quality records across all IDQ Regions.

The Senior Manager QA will report to the Director of Quality Assurance for Global Supply Hub and Quality Systems within International and Distribution Quality (IDQ)

Responsibilities:

  • Quality Management System (QMS) Subject Matter Authority (SME) - Senior Manager serves as the IDQ SME for Learning and Performance and deviation quality processes within Amgen QMS. Represents IDQ at Global Amgen networks and fulfills the role of QMS "Site SME".
  • Staff Management - Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program. Leads a culture of safety.
  • Quality Oversight of Global Supply Hub operations - Ensures the Quality Management System processes are executed in accordance with established procedures. Provides direction and decision making for Quality system records and report such as investigations, Corrective Actions/Preventative Actions (CAPAs) and Change Controls. Performs transportation lane review and approval as necessary. Reviews and approves records and reports. May serve as record or report owner. Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations.
  • Continuous Improvement - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Lean Transformation Operational Perfection program to develop stronger capabilities in continuous improvement.
  • Partner on cross-functional and cross-site teams to develop and implement business processes related to use and handling of single use systems.
  • Provide quality assessments and propose strategic direction support defect reduction, improving efficiency, reducing lead times and growing capabilities to achieve interpersonal success.
  • Communicate with all levels of the organization, facilitate development of solutions to critical business issues and define objectives to enable effective metric generation and reporting.
  • Assess, develop, measure and interpret process performance metrics.
  • Management of expenditures and work force model criteria to support business initiatives for department, site and interpersonal needs


BASIC QUALIFICATIONS:

Doctorate degree

Or

Master's degree and 3 years of quality or packaging experience within a cGMP regulated manufacturing environment

Or

Bachelor's degree and 5 years of quality or packaging experience within a cGMP regulated manufacturing environment

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

PI118538433

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94329<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/><b>Summary:</b><br><br>The QA Specialist position provides Quality oversight of Amgen's Global Supply Chain operations with specific emphasis on daily support of North American Hub operations in AML.<br><br>Under general supervision, the role provides support and compliance oversight to Global Supply Hub (GSH) staff in the execution of their processes, procedures, and use of quality systems. Daily duties include purposeful presence and face to face partnership with GSH staff and quality co-workers within the GSH work area or remotely when necessary. A successful candidate will demonstrate an ability to provide robust Quality Advice with specific skills in interpretation and application of Good Distribution Practices. Additional responsibilities will include the following:<br><ul><li>Provides Quality Oversight of daily GSH through face to face partnership, as needed</li><li>Performs Transportation Lane review and approval</li><li>Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations</li><li>Provides quality expertise, with specific emphasis on Good Distribution Practices knowledge, and mentorship to operational staff within GSH</li><li>Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports</li><li>Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, Safety, and Controls.</li><li>Participates in Amgen internal/external audits and inspections. May directly work well with regulatory agencies during on-site inspections</li><li>Actively participate in continuous improvement initiatives and projects as necessary</li></ul><br><br>The Senior Manager Quality Assurance (QA) will direct a team of QA professionals and provide Quality Management System (QMS) process subject matter expertise for International and Distribution Quality (IDQ)<br><br>The Senior Manager's team will provide Quality oversight in support Global Supply Chain (GSC) operations and include daily oversight of Global Supply Hub operations.<br><br>In addition, the Senior Manager's team will provide QA contact role for Quality records across all IDQ Regions.<br><br>The Senior Manager QA will report to the Director of Quality Assurance for Global Supply Hub and Quality Systems within International and Distribution Quality (IDQ)<br><br><b>Responsibilities:</b><br><br><ul><li><b>Quality Management System (QMS) Subject Matter Authority (SME)</b> - Senior Manager serves as the IDQ SME for Learning and Performance and deviation quality processes within Amgen QMS. Represents IDQ at Global Amgen networks and fulfills the role of QMS "Site SME".</li><li><b>Staff Management</b> - Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgen's talent management program. Leads a culture of safety.</li><li><b>Quality Oversight of Global Supply Hub operations</b> - Ensures the Quality Management System processes are executed in accordance with established procedures. Provides direction and decision making for Quality system records and report such as investigations, Corrective Actions/Preventative Actions (CAPAs) and Change Controls. Performs transportation lane review and approval as necessary. Reviews and approves records and reports. May serve as record or report owner. Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and executed in accordance with established procedures and applicable regulations.</li><li><b>Continuous Improvement</b> - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Lean Transformation Operational Perfection program to develop stronger capabilities in continuous improvement.</li><li>Partner on cross-functional and cross-site teams to develop and implement business processes related to use and handling of single use systems.</li><li>Provide quality assessments and propose strategic direction support defect reduction, improving efficiency, reducing lead times and growing capabilities to achieve interpersonal success.</li><li>Communicate with all levels of the organization, facilitate development of solutions to critical business issues and define objectives to enable effective metric generation and reporting.</li><li>Assess, develop, measure and interpret process performance metrics.</li><li>Management of expenditures and work force model criteria to support business initiatives for department, site and interpersonal needs</li></ul><br><br><b>BASIC QUALIFICATIONS:</b><br><br>Doctorate degree<br><br><b>Or</b><br><br>Master's degree and 3 years of quality or packaging experience within a cGMP regulated manufacturing environment<br><br><b>Or</b><br><br>Bachelor's degree and 5 years of quality or packaging experience within a cGMP regulated manufacturing environment<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and uses 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>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br><br>We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.<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/E5wMYdfMXJ8kUY5bsXman"> <p>PI118538433</p>
Posted: 2020-02-29 Expires: 2020-03-31

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Specialist QA

Amgen
Juncos, Puerto Rico 00777

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