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QC Laboratory Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeAnalytical Full time €60,000 - €80,000

Job Opportunity

Are you a detail-oriented and analytical individual looking for a challenging role in Quality Control?

  • We are seeking a highly motivated and experienced QC Associate to join our team.

Key Responsibilities

  • Perform analytical testing of various materials and equipment, including EU release, commercial, stability, utilities, raw materials, and validation.
  • Plan and perform multiple complex routine and non-routine methods and procedures.
  • Report, evaluate, back up, archive, trend, and approve analytical data.
  • Troubleshoot problems and communicate with stakeholders.
  • Initiate and implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Review protocols and perform assay validation and equipment qualification when required.
  • Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.

Requirements

  • Bachelor's degree in a Science related field is required.
  • 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  • Demonstrated ability to work independently and deliver right first-time results.
  • Works under minimal directions and is guided by objectives of the department or assignment.
  • 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.
  • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.
  • The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.