Lead Quality Assurance Specialist

4 days ago

Cork, Cork, Ireland beBeeMicrobiologist Full time €90,000 - €120,000
Job Description

Sr. Staff Microbiologist Role

About the Job:

  • Develop and implement a local quality strategy to ensure safe, high-quality clean and sterile products while maintaining regulatory compliance.
  • Oversight of key processes including cleaning, cleanroom, sterilization, and product testing.
  • Coach, mentor, and drive awareness among other functions in the area of Micro & Sterility.
  • Subject matter expert on internal and external regulatory requirements (Corporate, FDA, ISO) and local procedure owner.
  • Analyze sampling and monitoring data, applying statistical and analytical techniques to determine control and trends.
  • Review and approve Cleaning / Cleanroom Equipment/ Process qualification/ validation / monitorings/ test reports.
  • Communicate and resolve product issues causing supply chain disruptions.
  • Collaborate with global teams across sites for cleaning, sterilization, and environmental matters.
  • Identify opportunities to drive efficiencies and margin improvements.
  • Ensure compliance to Micro & Sterility standards in product transfers and new product introductions.
Requirements

Qualifications:

  • Bachelor's degree or Master's in Microbiology or equivalent.
  • Minimum 6 years of relevant experience.
  • 2 years of Microbiology-related experience.
  • Experience interacting with regulatory agencies required.
  • Thorough knowledge of US and International Medical Device Regulations and standards in Microbiology.
  • Strong communication, project management, and influencing skills.
  • Ability to manage multiple tasks simultaneously.
  • Strong interpersonal and written/oral communication skills.
  • Critical thinking and problem-solving skills.
  • Highly developed analytical skills.
  • Proven ability to work independently.
  • Experience in working in a compliance risk situation.
  • Proficiency in statistical techniques, data review, and analysis.
  • High level of PC skills with Microsoft Office proficiency.

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