Quality Control Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €45,000 - €55,000
Job Overview

The position of QC Associate plays a pivotal role in the quality control function, encompassing various activities such as analytical testing, equipment validation, and method transfers.

Key Responsibilities:
  • Apply principles of GMP QC analytical laboratories to ensure adherence to regulatory standards.
  • Stay abreast of related regulatory considerations, compliance issues, and scientific advancements.
  • Design and execute analyses with efficiency and accuracy.
  • Develop and implement complex routine/non-routine methods and procedures for assays.
  • Compile, evaluate, back-up/archive, trend, and approve analytical data.
  • Resolve problems, communicate effectively with stakeholders, and initiate changes in controlled documents.
  • Participate in audits, initiatives, and projects across departments or organizations.
  • Review protocols, validate assays, and qualify/verify equipment when necessary.
Qualifications and Skills:
  • A Bachelor's degree in a Science-related field is mandatory.
  • At least 4 years of experience in biopharmaceutical QC or relevant quality control/GMP laboratory experience in pharmaceuticals or medical devices.
  • Familiarity with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  • Demonstrated ability to work independently and deliver high-quality results.
  • Works under minimal direction, guided by departmental objectives or assignments.
  • References technical standards, principles, theories, and precedents as needed.
  • May set project timeframes and priorities based on project objectives and ongoing tasks.
  • Recognizes and escalates problems.
  • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills.

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