Compliance and QA Specialist II
6 days ago
We are looking for a highly skilled Compliance and QA Specialist II to join our team. In this role, you will be responsible for executing audit strategies, leading process audits, and monitoring quality to maintain inspection readiness.
Key Responsibilities:- Provide QA support during client audits and regulatory inspections to assess suitability, effectiveness, and compliance with applicable standards and regulations.
- Collaborate with site management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
- Support client due diligence and quality audits as well as regulatory inspections.
You will have the opportunity to work independently and as part of a team, utilizing your analytical and problem-solving skills to execute audit strategies and monitor quality.
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Auditing and Compliance Specialist II
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob DetailsThe Compliance Auditor II - Quality Assurance Specialist is responsible for ensuring FUJIFILM Diosynth Biotechnologies' products meet regulatory requirements and industry standards.This position works closely with site management to develop and implement effective quality systems, ensuring the organization's products meet the highest standards of...
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Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeThe Quality Assurance - Compliance Specialist II - Audit and Inspection plays a critical role in ensuring regulatory compliance across the organization. This professional collaborates with site management to instill a culture of quality, providing coaching on GMP principles and their underlying rationales. They also mentor peers towards achieving...
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Quality Assurance Specialist II
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob DescriptionThe Auditing and Compliance Specialist II plays a vital role in ensuring FUJIFILM Diosynth Biotechnologies' products meet regulatory requirements and industry standards.This position works collaboratively with site management to instill a 'Quality Culture,' mentoring peers toward achieving organizational and individual...
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Compliance Auditor II
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob SummaryFUJIFILM Diosynth Biotechnologies seeks a highly skilled Regulatory Compliance Specialist II - Audit and Inspection Expert to join our team.In this critical role, you'll collaborate with site management to develop and implement effective quality systems, ensuring the organization's products meet the highest standards of quality, safety, and...
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Regulatory Compliance Specialist II
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob OverviewThe Regulatory Compliance Specialist II - Audit and Inspection Expert will provide critical support to ensure compliance with regulatory requirements and industry standards.This role will work closely with site management to develop and implement effective quality systems, ensuring the organization's products meet the highest standards of...
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Regulatory Compliance Officer
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Overview:Fujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance-Compliance Specialist II-Audit and Inspection to join our team. This role will support all associated responsibilities in compliance with quality policies and site SOPs to ensure regulatory compliance.\About the Role:This position will work collaboratively with site...
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Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition OverviewThe Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are...
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Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are...
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Quality Control Specialist
6 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeWe are seeking an experienced Quality Assurance - Compliance Specialist II - Audit and Inspection to join our team. In this role, you will be responsible for providing QA support during client audits and regulatory inspections, collaborating with site management to instill a culture of quality, and mentoring peers towards achieving organizational and...
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Audit and Inspection Coordinator
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Description:Fujifilm Diosynth Biotechnologies is seeking 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.\About the Position:This role will require the successful candidate to work collaboratively with site...
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Quality Assurance Specialist
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob 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.\About Fujifilm Diosynth Biotechnologies:We are a global leader in the development and manufacturing of...
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Qa Analyst Iii
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition OverviewThe Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying...
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Senior Qa Analyst
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition OverviewThe Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities,...
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QA Analyst III
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying...
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Senior QA Analyst
7 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities,...
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QA Systems Analyst
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob DescriptionWe are seeking a skilled QA Systems Analyst to join our team. The successful candidate will be responsible for analyzing and improving our Quality systems to ensure compliance with regulatory requirements.Main Responsibilities:Analyze and improve Quality systems to ensure compliance with regulatory requirements.Develop and implement Quality...
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Microbiologist II Role
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time**Job Summary**The role of the Microbiologist II is to ensure compliance with cGMP regulations in the Quality Control Laboratory at FUJIFILM Diosynth Biotechnologies. This involves performing microbiological testing, collecting environmental monitoring samples, and maintaining a clean and organized laboratory environment.Responsibilities:Perform...
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Qa - Director Quality Compliance
5 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition OverviewThe Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.Responsibilities will include one or more PQS sub-systems: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.Lead the assigned team to...
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Pharmaceutical QA Expert
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeOverviewThe Pharmaceutical QA Expert role is crucial in ensuring the quality and safety of our products. We are looking for an experienced professional to lead our Quality Assurance team.Main Duties:Develop and implement Quality policies, procedures, and processes to ensure compliance with regulatory requirements.Conduct inspections of final product...
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Regulatory Compliance Expert
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob SummaryThe Senior Quality Assurance (QA) Analyst will be responsible for ensuring the quality of our products by reviewing and approving basic and technical documentation, drafting and reviewing internal Quality policies and procedures, performing product-related activities, conducting Quality audits, and identifying process and Quality System...