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Specialist Quality Assurance

Employer
Amgen
Location
Providence, RI
Start date
Aug 31, 2022

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this! Lets change the world!

The Specialist Quality Assurance will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.

Responsibilities:

Serve as Owner or QA Contact for Minor and Major Deviations. Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.

  • Initiate and own QA Deviations (Major, Minor) as needed

  • Serve as QA contact for Major, Minor deviations

  • Serve as Owner or QA contact for CAPA and Effectiveness Verification (EV) records

  • Serve as Quality approver for problem records in ServiceNow

  • Review and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices

  • Review and approve operational and administrative SOPs and Work Instructions

  • Review and approve Change Controls (QA Contact role for CCMS and ServiceNow changes)

  • Review and approve Data Integrity Assessments

  • Review and approve 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 (e.g., Qualitative information, Quantitative research, Trend data)

  • Anticipates and prevents potential problems

  • May be responsible for specific GxP Computerized Systems programs and/or projects

  • Independently develops solutions that are thorough, practical and consistent with functional objectives

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications

Doctorate

OR

Masters degree and 3 years of quality experience

OR

Bachelors degree and 5 years of quality experience

OR

Associates degree and 10 years of quality experience

OR

High School Diploma/ GED and 12 years quality of experience

Experience serving as QA Contact for Major and Minor Deviations

Experience in GxP computerized systems validation

Preferred Qualifications

  • Bachelors degree in Computer Science or related field and 5+ years of Software and Systems Quality assurance experience

  • Experience owning Major and Minor Deviations

  • Technical knowledge of IS systems such as LIMS, CDOCS, SAP, Maximo

  • Ability to interpret and apply GxP (GMP, GLP, GCP, GPvP, GDP)

  • Broad technical knowledge within own specialty area

  • Knowledge of industry and business principles

  • Demonstrated problem solving abilities

  • Contributes to work group/team by ensuring quality of tasks/ services provided by self and others

  • Provides training and guidance to others

  • Extends capabilities by working closely with senior staff/ experts within and outside the internal organization

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com
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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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