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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 be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities:

  • Review and verify documentation related to finished goods products to ensure consistency and compliance with regulatory requirements.
  • Support the Core QA department in daily activities and provide training and support to other QA staff as needed.
  • Maintain a solid understanding of regulatory and quality system requirements, including ISO13485 and FDA CFR.
  • Prepare and edit Standard Operating Procedures (SOPs) and review batch manufacturing documentation prior to final product release.
  • Enter data into systems and perform data checks to ensure accuracy and completeness.
  • Compile customer documentation packages and provide customer-facing responses to inquiries.
  • Utilize Trackwise system for non-conformances, deviations, and CAPA.
  • Participate in personal development to improve skills and knowledge relevant to the position.
  • Upload SOPs and WINs to the Training System and record archiving.
  • Responsible for housekeeping of all quality document storage areas and wear appropriate PPE as required.

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. Must be able to work overtime to complete daily tasks.