QC Micro Analyst

  • Dublin South
  • Temporary 12 months
  • JO-1903-64310_1551957859

Summary

Responsibilities

  • Perform analytical testing as a main priority with efficiency and accuracy
  • With a high degree of technical flexibility, work across diverse areas within the lab
  • 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.
  • 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 perform assay validation 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
  • May participate in lab investigations.
  • May provide technical guidance.
  • May train others.
  • May contribute to regulatory filings.
  • May represent the department/organization on various teams
  • May interact with outside resources


Requirements

  • Bachelor's degree in a science discipline
  • Bio-pharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
  • 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
  • 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
  • Decision Making skills
  • Teamwork and Coaching others
  • 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

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