Quality Assurance Lead Auditor

1 month ago


College Station, Texas, United States FUJIFILM Diosynth Biotechnologies Full time
Job Title: Quality Assurance Lead Auditor

FUJIFILM Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Lead Auditor to join our team. As a key member of our Global Supplier Quality Management team, you will be responsible for managing and leading the Supplier auditors performing Supplier Audits regionally and internationally.

Key Responsibilities:
  • Lead the Supplier auditor team in performing audits, generating audit reports, and managing supplier CAPA to ensure required actions are completed within the required timeframe.
  • Collaborate with site management to instill a 'Quality Culture' by coaching in applying GMP Principles.
  • Support the organization in conducting internal audits and hosting audits/inspections.
  • Manage Supplier notification mailbox to ensure active management and delegation within the supplier team.
  • Develop metrics to provide visibility of audits due, planned audit dates, audits complete, audit reports process timelines, and overdue audits.
Requirements:
  • Bachelor's Degree in the Life Sciences/Engineering field and 3 years auditing experience within the Pharmaceutical/Medical Device industry.
  • Experience with Good Documentation Practices, cGMP/GLP regulations.
  • ASQ Quality Auditor Certification or equivalent.
Preferred Qualifications:
  • Leadership experience.
  • Knowledge and understanding of EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices.

FUJIFILM Diosynth Biotechnologies is an equal opportunity and affirmative action employer. We are committed to diversity and inclusion in the workplace.



  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job SummaryThe Supplier Quality Auditor Lead will be responsible for managing and leading the Supplier auditors performing Supplier Audits regionally and internationally following their assigned schedule in support of supplier integrity and oversight. This role will also support all associated supplier quality management and audit responsibilities in...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Job Title: Senior Quality Assurance Compliance AuditorJob Summary:The Senior Quality Assurance Compliance Auditor will be responsible for ensuring the quality and compliance of our products and processes. This role will involve conducting internal audits, reviewing and implementing quality policies and procedures, and providing guidance and training to...


  • College Station, Texas, United States Core Business Solutions Full time

    Job Title: Quality AuditorWe are seeking a highly skilled Quality Auditor to join our team at Core Business Solutions. As a Quality Auditor, you will play a vital role in ensuring our clients are compliant with ISO standards and audit-ready for external audits.Key Responsibilities:Conduct internal audits to support lead consultants and ensure clients are...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Quality Assurance Analyst IIIFujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Analyst III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Review and approve basic and technical documentation, including...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Quality Assurance SpecialistAt FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Review and approve basic and technical documentation, including...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Job Title: Quality Assurance SpecialistFujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Support the supplier quality program by ensuring all suppliers of...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Quality Assurance Specialist IIOverviewThe Quality Assurance Specialist II, Supplier Quality will be responsible for supporting the supplier quality program. This role will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key Responsibilities:Compliance: QA...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Quality Assurance Specialist IIIOverviewFUJIFILM Holdings America Corporation is seeking a highly skilled Quality Assurance Specialist III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Review and approve basic...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Quality Assurance Supervisor, Document ControlAt FUJIFILM Holdings America Corporation, we are seeking a highly skilled Quality Assurance Supervisor, Document Control to join our team. As a key member of our Quality Assurance department, you will be responsible for leading the QADC team in managing, metrics, and closure of Change Controls.Key...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist III to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve basic and technical documentation,...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Quality Assurance Specialist IIIOverviewFUJIFILM Holdings America Corporation is seeking a highly skilled Quality Assurance Specialist III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key Responsibilities:Review and approve...


  • College Station, Texas, United States Fujifilm Diosynth Biotechnologies Full time

    Job SummaryThe Quality Assurance (QA) Compliance Analyst II, Supplier Quality will be responsible for supporting the supplier quality program. This role will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key ResponsibilitiesCompliance: Ensure all suppliers meet regulatory...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job SummaryThe Quality Assurance Specialist II, Supplier Quality will be responsible for supporting the supplier quality program. This role will ensure all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.Key ResponsibilitiesCompliance: QA representative to external suppliers, support to the...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at FUJIFILM Diosynth Biotechnologies. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve basic and technical documentation, including Standard...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Senior Quality Assurance AnalystThe Senior Quality Assurance Analyst will play a critical role in ensuring the quality and compliance of our pharmaceutical products. This position will be responsible for reviewing and approving technical documentation, drafting and reviewing internal quality policies and procedures, and performing quality audit...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist II to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our Quality Assurance department, you will be responsible for supporting the supplier quality program and ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Senior Quality Assurance AnalystOverviewThe Senior Quality Assurance Analyst will play a critical role in ensuring the quality and compliance of our products. This position will be responsible for reviewing and approving documentation, drafting and reviewing quality policies and procedures, and performing quality audit functions.Key...


  • College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: QA Analyst IIIAt FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled QA Analyst III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical products.Key Responsibilities:Review and approve basic and technical...


  • College Station, Texas, United States Fujifilm Full time

    Job Title: Senior Quality Assurance Compliance SpecialistFujifilm is seeking a highly skilled Senior Quality Assurance Compliance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Develop and implement...


  • College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job Title: Quality Assurance Specialist IIIOverviewFUJIFILM Holdings America Corporation is seeking a highly skilled Quality Assurance Specialist III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.Responsibilities:Review and approve basic and technical...