28 days old

Undergrad Intern - Ops (Specialist QA)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118799918
Amgen

Job ID: R-94576
Location: Thousand Oaks, CA, US 91360

Amgen is the world's leading biotechnology company. Nurtured on a foundation of strong values, Amgen is deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Our mission is to serve patients, and we encompass this with each initiative, goal and task we have in mind!

Amgen's 10 - 12 week internship program offers meaningful project experiences that impact patient's lives. This internship provides the opportunity for executive and social networking events and to participate in community volunteer projects while providing a competitive compensation.

Limited relocation housing and/or miscellaneous allowance may be available for eligible candidates.

At Amgen, our mission is simple: to serve patients. Our Corporate Computerized System validation team provides essential services that enable us to better pursue this mission.

The Specialist Quality Assurance intern will actively partner with the Director of Corporate Validation and a fellow Specialist QA from the Validation team to learn and participate in supporting all phases of qualification/validation which includes evaluating projects and supporting activities associated to the System Development Lifecycle of a Computerized System.

Responsibilities include:

Review validation/qualification packages for completeness and accuracy, to ensure there is sound rationale which meet our regulatory expectations/requirements and are in compliance with validation policies and procedures. Additionally, the intern will compare results against acceptance criteria and bring exceptions or deviations to management's attention and support initiation of necessary improvements and corrections to established systems and processes. Initiate, execute, and track completion of Change Control and Non Conformance requests related to computer systems. Computerized System Validation Lifecycle Management includes some of the following tasks:
  • Update and track group goals by communicating with goal owners
  • Create draft gap assessments for regulation to process
  • Create draft gap assessments for process overview to procedures
  • Create draft gap assessments for QMS procedures to procedures
  • Review the Configuration Items for Systems
  • Communicate System Owners of Computerized Systems to request updates to Configuration Items
  • Track updates to Configuration Items
  • Use the Inspection Readiness worksheet to document System deliverables
  • Help create the Inspection Readiness Playbook
  • Communicate with System Owners and Business Owners to track progress of implementing the new System Description
  • Communicate with System Owners to track progress of implementing the new Supplier Template
  • Act as reviewer and approver for operational SOP's and Work Instructions
  • Review System Life Cycle Documents (i.e. test protocols) before use in production
  • Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
    • Qualitative information
    • Quantitative research
    • Trend data
  • Forecasts, models and utilizes advanced analytical tools
  • Anticipates and prevents potential problems


Basic Qualifications

Amgen requires that all individuals applying for an undergraduate internship or an undergraduate co-op assignment at Amgen must meet the following criteria:

18 years or older

Currently enrolled in a full time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent

Completion of one year of study from an accredited college or university prior to the internship commencing

Enrolled in a full time Bachelor's or Combined Bachelor's/Master's degree program following the potential internship or co-op assignment with an accredited college or university

Must not be employed at the time the internship starts

Preferred Qualifications

Degree concentration(s) in Science, Validation, Engineering or related field

Knowledge of Microsoft Word, Excel and Power Point

Experience with Visio is a plus

Detail oriented

Demonstrated personal initiative, self-motivation, flexibility and adaptability

Ability to effectively operate independently and cross functionally

Only candidates who apply via http://careers.amgen.com/ will be considered. Please search for Keyword 94576.

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.

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.

#LI-DNI

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.

PI118799918

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94576<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is the world's leading biotechnology company. Nurtured on a foundation of strong values, Amgen is deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Our mission is to serve patients, and we encompass this with each initiative, goal and task we have in mind!<br><br>Amgen's 10 - 12 week internship program offers meaningful project experiences that impact patient's lives. This internship provides the opportunity for executive and social networking events and to participate in community volunteer projects while providing a competitive compensation.<br><br>Limited relocation housing and/or miscellaneous allowance may be available for eligible candidates.<br><br>At Amgen, our mission is simple: to serve patients. Our Corporate Computerized System validation team provides essential services that enable us to better pursue this mission.<br><br>The Specialist Quality Assurance intern will actively partner with the Director of Corporate Validation and a fellow Specialist QA from the Validation team to learn and participate in supporting all phases of qualification/validation which includes evaluating projects and supporting activities associated to the System Development Lifecycle of a Computerized System.<br><br><b>Responsibilities include:</b><br><br>Review validation/qualification packages for completeness and accuracy, to ensure there is sound rationale which meet our regulatory expectations/requirements and are in compliance with validation policies and procedures. Additionally, the intern will compare results against acceptance criteria and bring exceptions or deviations to management's attention and support initiation of necessary improvements and corrections to established systems and processes. Initiate, execute, and track completion of Change Control and Non Conformance requests related to computer systems. Computerized System Validation Lifecycle Management includes some of the following tasks:<br><ul><li>Update and track group goals by communicating with goal owners</li><li>Create draft gap assessments for regulation to process</li><li>Create draft gap assessments for process overview to procedures</li><li>Create draft gap assessments for QMS procedures to procedures</li><li>Review the Configuration Items for Systems</li><li>Communicate System Owners of Computerized Systems to request updates to Configuration Items</li><li>Track updates to Configuration Items</li><li>Use the Inspection Readiness worksheet to document System deliverables</li><li>Help create the Inspection Readiness Playbook</li><li>Communicate with System Owners and Business Owners to track progress of implementing the new System Description</li><li>Communicate with System Owners to track progress of implementing the new Supplier Template</li></ul><ul><li>Act as reviewer and approver for operational SOP's and Work Instructions</li><li>Review System Life Cycle Documents (i.e. test protocols) before use in production</li><li>Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information<ul><li>Qualitative information</li><li>Quantitative research</li><li>Trend data</li></ul></li><li>Forecasts, models and utilizes advanced analytical tools</li><li>Anticipates and prevents potential problems</li></ul><br><br><b>Basic Qualifications </b><br><br>Amgen requires that all individuals applying for an undergraduate internship or an undergraduate co-op assignment at Amgen must meet the following criteria:<br><br>18 years or older<br><br>Currently enrolled in a full time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent<br><br>Completion of one year of study from an accredited college or university prior to the internship commencing<br><br>Enrolled in a full time Bachelor's or Combined Bachelor's/Master's degree program following the potential internship or co-op assignment with an accredited college or university<br><br>Must not be employed at the time the internship starts<br><br><b>Preferred Qualifications</b><br><br>Degree concentration(s) in Science, Validation, Engineering or related field<br><br>Knowledge of Microsoft Word, Excel and Power Point<br><br>Experience with Visio is a plus<br><br>Detail oriented<br><br>Demonstrated personal initiative, self-motivation, flexibility and adaptability<br><br>Ability to effectively operate independently and cross functionally<br><br>Only candidates who apply via http://careers.amgen.com/ will be considered. Please search for Keyword 94576.<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>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>#LI-DNI<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/eorA8VINerMPCjxYhdXDl"> <p>PI118799918</p>

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Posted: 2020-03-06 Expires: 2020-04-06

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Undergrad Intern - Ops (Specialist QA)

Amgen
Thousand Oaks, CA 91360

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