Senior QA Associate

1 week ago

Dublin, Dublin City, Ireland beBeeQuality Full time €59,783 - €75,127

Senior Quality Assurance Associate Job Description

The primary responsibility of this role is to ensure the quality and integrity of our pharmaceutical products. As a Senior Quality Assurance Associate, you will be responsible for planning and performing analyses with great efficiency and accuracy.

  • You will 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.
  • Review protocols and perform assay validation and equipment qualification/verifications when required.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • May contribute to regulatory filings.
  • May conduct lab investigations as necessary.
  • Evaluate lab practices for compliance on a continuous basis.
  • Approve lab results.

Key Skills and Qualifications

  • Be very proficient in the use of Microsoft Word, Excel etc.
  • Have strong communication and technical writing skills.
  • Investigation skills.
  • Be detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
  • Be a self-starter and capable of working on own initiative.
  • Strong teamwork skills.
  • Proven track record of meeting deadlines.
  • Experience with analytical techniques such as Compendial testing would also be advantageous.

Bachelor's Degree Requirements

  • A Bachelor's degree in a Science related field is required.
  • 3+ 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.

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