Amgen

Associate QC Micro (24/7)

Amgen  •  Dublin, IE (Onsite)  •  13 days ago
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Job Description

Career Category

Quality

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

Specific Job Duties:

  • Environmental Monitoring of Grade 8/9 Cleanrooms
  • Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
  • Reading of Environmental Monitoring Plates
  • Bioburden testing of water & disinfectants
  • Water sampling
  • Testing of In Process samples such as pH
  • Initiate and/or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

Basic Qualifications

  • Bachelors degree in a science discipline
  • Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Preferred Qualifications

  • Experience working in an aseptic cleanroom performing Environmental Monitoring
  • Proficient in the use of LIMS & LMES
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products


Competencies

  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
  • Flexibility – the EM role often encounters changing priorities on a daily basis
  • Problem solving skills
  • Experience with Regulatory inspectors and interacting with inspectors desirable
  • Demonstrated ability to work independently and deliver right first time results
  • Works under minimal direction
  • Work is guided by objectives of the department or assignment
  • Follows procedures
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments.
  • Recognizes and escalates problems
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies.
Amgen

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Thousand Oaks, CA
Year Founded
1980
Website
amgen.com
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