Sr Associate QC
Amgen Inc
Dublin, Dublin
1d ago

Specific Job Duties :

  • Perform Environmental Monitoring in aseptic processing areas.
  • Perform analytical testing with efficiency and accuracy
  • Report, evaluate, back-up / archive, trend and approve analytical data.
  • Troubleshoot, solve problems and communicate with stakeholders.
  • Initiate and / or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Write protocols and performvalidation and equipment qualification / verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
  • Approve lab results
  • Working as part of a 24 / 5 shift pattern.
  • Basic Qualifications

  • Bachelor's degree in a science discipline
  • Preferred Qualifications

  • Experience in a variety of techniques, including Environmental Monitoring, Microbial Identification, Media prep, Water Sampling, pH testing, density testing, Protein concentration testing.
  • Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
  • 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
  • Skills

  • Take initiative to identify and drive improvements
  • Excellent verbal and written communication skills Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basis
  • Competencies

  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Change Control, Trackwise, SAP and EDMQ an advantage
  • Experience with Regulatory inspectors and interacting with inspectors desirable
  • Demonstrated ability to work independently and deliver right first time resultsWorks under minimal directionWork is guided by objectives of the department or assignmentFollows 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 problemsDemonstrated leadership and communication skillsAuditing documentation and operation processDemonstrated ability to interact with regulatory agencies
  • Specific Job Duties :

    Plan and perform multiple, complex routine / non-routine methods and procedures and a large variety of assays.Report, evaluate, back-

    up / archive, trend and approve analytical data.Troubleshoot, solve problems and communicate with stakeholders.

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