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Sr. Associate QA

Company: Amgen
Location: Thousand Oaks
Posted on: September 22, 2022

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.LiveWhat you will doLets do this! Lets change the world!The Sr. Associate QA will be a member of the Amgen Thousand Oaks (ATO) Incoming Quality Assurance Team. The Sr. Associate QA will be responsible for the inspection, sampling and batch record review of raw materials, and commercial and clinical biopharmaceutical products.The Sr. Associate QA provide Quality Assurance oversight for warehouse and supply chain operations for commercial and clinical biopharmaceutical products.The Sr. Associate QA will provide guidance and direction to Production, Warehouse/Distribution staff in regards to compliance with quality policies, standards and procedures.The Sr. Associate QA may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.Responsibilities include:

  • Internal Quality Assurance support for GMP warehouse and inventory management operations
  • Perform inspection and sampling of raw materials, and commercial and clinical biopharmaceutical products
  • Review and provide Quality approval for electronic and paper incoming material receipt records, and GMP documentation such as work orders, investigation reports, deviation records, and other GMP records
  • Internal Quality Assurance support for creation and revision of GMP procedures including document review, approval, and archival
  • Support investigations/deviation reports for warehouse operations, incoming raw material receipts
  • Assess incoming product lots for compliance to specification requirements
  • Provide support for QA Reserve inspections and management
  • Alerts management of significant quality, compliance, supply, and safety risks
  • Participates as a QA team member process during regulatory inspections, third party audits, and internal audits
  • The successful candidate will have experience working in multiple GMP databasesWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.Basic Qualifications:
    • Master's Degree OR
    • Bachelor's Degree & 2 years of cGMP experience OR
    • Associate's degree & 6 years of cGMP experience OR
    • High school diploma/GED & 8 years of cGMP experiencePreferred Qualifications:
      • Quality and Manufacturing experience in biotech or Pharmaceutical industry
      • Bachelors Degree in Science field
      • Familiarity with basic project management tools
      • Ability to successfully manage workload to timelines
      • Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise, VeevaVault)
      • Demonstrated experience creating deviation technical assessments or equivalent
      • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.
      • Proficient with database use, including data input, archival, and query retrieval
      • Strong attention to detail and high degree of accuracy in task execution and GMP documentation
      • Highly effective verbal and written communication skills, strong interpersonal skills
      • Ability to complete tasks autonomously, provide updates to area manager, and identify potential issuesThriveSome of the vast rewards of working hereAs we work to develop treatments that take care of others, we also 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 GlassdoorAmgen 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 demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join UsIf 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.

Keywords: Amgen, Thousand Oaks , Sr. Associate QA, Other , Thousand Oaks, California

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