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Quality Assurance Specialist

2 months ago

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Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities:

  • Review and verify all documentation related to finished goods products to ensure compliance with regulatory requirements.
  • Highlight any inconsistencies or problems with the quality or compliance of products prior to final product release.
  • Support the daily activities of the Core QA department as required.
  • Maintain a solid understanding of regulatory and quality system requirements, including ISO13485 and FDA CFR.
  • Prepare new Standard Operating Procedures (SOPs) and edit/delete revised SOPs.
  • Review all batch manufacturing documentation in advance of final product release.
  • Enter data into systems and perform data checks.
  • Compile customer documentation packages.
  • Provide customer-facing responses to inquiries.
  • Utilize the Trackwise system for non-conformances, deviations, and CAPA.
  • Provide training and support to other QA staff and other departments within operations.
  • Participate in personal development to improve skills and knowledge relevant to the position.
  • Utilize the Agile system.
  • Upload SOPs and WINs to the Training System.
  • Record archiving and routine filing, and maintain housekeeping of quality document storage areas.
  • Wear and use appropriate PPE in accordance with instructions.

Requirements:

  • Minimum of HND in Quality or Science.
  • Minimum of two years' QA/QC experience in a relevant environment.
  • Knowledge of computer applications and current software (Word/Excel).

Working Conditions:

This role will work in an office environment but may require spending time in manufacturing and the warehouse. The ability to work overtime to complete daily tasks is essential.