Specialist QA

Company: Amgen
Location: West Greenwich
Posted on: November 22, 2021

Job Description:

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.Specialist QALiveWhat you will doLets do this. Lets change the world. In this vital role you will lead the delivery 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: 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 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, complete, 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
• Act as reviewer and approver for operational SOPs and Work Instructions
• Review of operational SOPs and Work Instructions
• Review and approve Change Controls
• 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
• Qualitative information
• Quantitative research
• Trend data
• Forecasts, models and uses advanced analytical tools
• Anticipates and prevents potential problems
• May be responsible for specific programs and/or projects
• Independently develops solutions that are thorough, practical and consistent with functional objectivesWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Quality Assurance professional we seek is a Specialist with these qualifications.Basic QualificationsDoctorateORMasters degree and 2 years of experienceORBachelors degree and 4 years of experienceORAssociates degree and 10 years of experienceORHigh School Diploma/ GED and 12 years of experiencePreferred Qualifications
  • Bachelors degree in Computer Science or related field and 5+ years of Software and Systems Quality assurance experience
  • Experience owning and serving as QA Contact for Major and Minor Deviations
  • Technical knowledge of IS systems such as LIMS, CDOCS, SAP, Maximo
  • Ability to interpret and apply GLPs, GCPs and GMPs
  • 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 organizationThriveSome of the vast rewards of working hereAs 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 GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.

Keywords: Amgen, Warwick , Specialist QA, Other , West Greenwich, Rhode Island