Associate Quality Control

AmgenHolly Springs, NC
Remote

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Quality Control What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will:

Requirements

  • Master’s degree (or foreign equivalent) in Microbiology, Biology, Biochemistry, or related field & completion of a university-level course, research project, internship, thesis, or one year of experience involving the following:
  • Quality control testing including: Bioburden, Endotoxin and Microbial Identification
  • Environmental Monitoring, utilities sampling, and knowledge of EM and utilities programs
  • Participating in or leading Deviations, CAPAs or investigations
  • Maintaining laboratory equipment, including coordination of maintenance and calibration programs
  • Supporting review or authorship of standard operating procedures, safety assessments, and technical reports
  • cGMP and GLP work environment and best practices

Responsibilities

  • Assist execution of equipment installation and qualification within the microbiology lab to support start-up
  • Support document review and authoring, including: standard operating procedures, safety assessments, methods, trend reports, microorganism assessments, and technical reports
  • Assist with execution of Environmental Monitoring Performance Qualification activities to support establishment of environmental monitoring program
  • Perform routine environmental monitoring and utilities sampling
  • Perform routine quality control testing, including Bioburden, Endotoxin, Microbial Identification, Polymerase chain reactions, and total organic carbon
  • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope
  • Participate in deviations, CAPAs, and cross functional investigations
  • Assist with general lab setup and 5S

Benefits

  • stock
  • retirement
  • medical
  • life and disability insurance
  • eligibility for an annual bonus
  • Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
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