Amgen Sr Associate QC - Microbiology (Shift) in Dublin, Ireland

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 skills

  • Escalate 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 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

  • Demonstrated leadership and communication skills

  • Auditing documentation and operation process

  • Demonstrated ability to interact with regulatory agenciesSpecific 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.