Quality Assurance Specialist

6 days ago


Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Job Summary:
Fujifilm Diosynth Biotechnologies seeks a Quality Assurance-Compliance Specialist II-Audit and Inspection to support all associated responsibilities in compliance with quality policies and site SOPs to ensure regulatory compliance.

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About Fujifilm Diosynth Biotechnologies:
We are a global leader in the development and manufacturing of biopharmaceuticals. Our mission is to create innovative solutions that improve human health and quality of life.

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Key Responsibilities:

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  • Work collaboratively with site management to instill a 'Quality Culture' by coaching in the application of GMP Principles.\
  • Mentor peers towards achieving organizational and individual goals.\
  • Provide QA support to the organization during client audits and regulatory inspections.\
  • Display critical thinking expertise, with the ability to define and implement a strategic approach to audit based on compliance and business knowledge.\
  • Support client due diligence and Quality audits as well as regulatory inspections.\
  • Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.\
  • Ensure no overdue training or site actions.\
  • Support other QA teams and other functions in completion of site actions.\
  • Provide cGMP guidance to other functions such as Manufacturing, Facilities, QC, Warehouse, and Validations.\
  • Support Site Readiness Preparation for Regulatory Inspections.\
  • Stay aware and up to date with agency regulations, guidance documents, and industry best practices.\\/ul>

Required Skills & Qualifications:

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  • Excellent written and oral communication skills.\
  • Excellent organizational, analytical, data review, and report writing skills.\
  • Able to set personal performance goals and provide input to departmental objectives.\
  • Able to multitask and easily prioritize work.\\/ul>\

Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



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