Quality Assurance-Compliance Specialist II-Audit and Inspection

6 days ago

Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Position Overview

The 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 Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

Job Description

Essential Functions:

  1. Work collaboratively with site management to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles.
  2. Mentor peers towards achieving organizational and individual goals.
  3. Provide QA support to the organization during client audits and regulatory inspections to determine suitability, effectiveness, and compliance with applicable standards and regulations.
  4. Display critical thinking expertise, with the ability to define and implement a strategic approach to audit based on compliance and business knowledge.
  5. Support client due diligence and Quality audits as well as regulatory inspections.
  6. Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
  7. Ensure no overdue training or site actions. Support other QA teams and other functions in completion of site actions.
  8. Provide cGMP guidance to other functions such as Manufacturing, Facilities, QC, Warehouse, and Validations.
  9. Support Site Readiness Preparation for Regulatory Inspections.
  10. Stay aware and up to date with agency regulations, guidance documents, and industry best practices, to ensure Fujifilm, Texas site is held to current standards.
  11. Execute audit strategy and lead process audits.
  12. Monitor quality in support of maintaining inspection readiness.
  13. Provide support during regulatory inspections or customer audits as requested by the company, before, during and/or after the event.
  14. Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  15. Ensure audit and inspection reports are responded to on time.
  16. Work on complex problems in which analysis of situations or data requires in-depth evaluation of various factors from many sources. Interpret GMP regulations in the resolution of problems and in the design of systems, processes, or procedures.
  17. Effectively plan, organize, and execute work that ensures deliverables are consistently met.
  18. All other duties as assigned.

Required Skills & Abilities:

  1. Excellent written and oral communication skills.
  2. Excellent organizational, analytical, data review, and report writing skills.
  3. Ability to set personal performance goals and provide input to departmental objectives.
  4. Ability to multitask and easily prioritize work.

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. While performing the duties of this job, the employee is regularly required to:

  1. Experience prolonged standing, some bending, stooping, and stretching.
  2. Ability to sit for long periods to work on a computer.
  3. Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
  4. Wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
  5. Lifting up to 25 pounds on occasion.
  6. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
  7. Willingness to work flexible hours, including weekends and off-shift hours, as needed to support manufacturing activities.
  8. Willingness to travel occasionally, as needed.
  9. Attendance is mandatory.

Qualifications:

  1. High school diploma or GED and six (6) years of experience in a regulated industry, including two (2) years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
  2. Associate degree in a related science concentration with 4 years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
  3. Bachelor's degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
  4. Master's degree in a related science concentration with 1 year of experience of cGMP supporting pharmaceutical or biotechnology products.

Preferred Qualifications:

  1. Certified Quality Auditor.
  2. Degree in Biology, Chemistry, or Engineering.
EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).

#J-18808-Ljbffr

  • Quality Assurance-Compliance Specialist II-Audit and Inspection Expert

    6 days ago

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

    The 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...

  • Quality Assurance-Compliance Specialist Ii-Audit And Inspection

    4 days ago

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

    Position 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...

  • Auditing and Compliance Specialist II

    5 days ago

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

    Job 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...

  • Quality Control Specialist

    6 days ago

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

    We 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...

  • Audit and Inspection Coordinator

    4 days ago

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

    Job 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...

  • Regulatory Compliance Specialist II

    5 days ago

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

    Job 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...

  • Compliance Auditor II

    5 days ago

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

    Job 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...

  • Quality Assurance Specialist II

    5 days ago

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

    Job 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...

  • Compliance and QA Specialist II

    6 days ago

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

    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,...

  • Quality Assurance Specialist

    4 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.\About Fujifilm Diosynth Biotechnologies:We are a global leader in the development and manufacturing of...

  • Regulatory Compliance Officer

    4 days ago

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

    Job 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...

  • Quality Assurance Specialist

    5 days ago

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

    Job SummaryWe are seeking a skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and compliance of our products in accordance with regulatory requirements.Main Responsibilities:Review and approve documentation, including Standard Operating Procedures, Batch Production Records, and...

  • Quality Assurance Specialist

    5 days ago

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

    **Quality Assurance Specialist - Biomanufacturing**We are seeking a Quality Assurance Specialist to join our team. As a key member of our quality assurance group, you will be responsible for ensuring that all manufacturing processes are conducted in accordance with Good Manufacturing Practices (GMP) and company policies.The ideal candidate will have a strong...

  • Regulatory Compliance and Quality Assurance Professional

    6 days ago

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

    In this role, you will work closely with site management to foster a culture of quality, providing guidance on GMP principles and their application. You will also be responsible for mentoring peers towards achieving organizational and individual goals.Responsibilities:Collaborate with site management to ensure quality systems support cGMP manufacturing of...

  • Quality Assurance Leader

    6 days ago

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

    Position OverviewThe Quality Assurance (QA) Operations Supervisor will be responsible for overseeing the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site Standard Operating Procedures (SOPs) to ensure regulatory compliance.Reports to: Senior Manager, Quality...

  • Quality Assurance Compliance Coordinator

    5 days ago

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

    Position OverviewThis position plays a key role in ensuring compliance with regulatory requirements in the manufacturing process.Main ResponsibilitiesEnsure required Management and Quality approvals on final investigations while satisfying established due dates.Facilitate corrective and preventive action agreement with stakeholders.Support client due...

  • Quality Assurance Analyst

    4 days ago

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

    Job SummaryThe Senior QA Specialist will be responsible for ensuring the quality of products and services in a fast-paced environment. The ideal candidate will have a strong background in quality assurance and excellent analytical skills.Responsibilities- Review and approve documentation with minimal supervisory oversight- Draft and review internal quality...

  • Quality Assurance Director

    5 days ago

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

    Job Description:Fujifilm Diosynth Biotechnologies seeks a highly skilled Director of Pharmaceutical Quality to lead the development, implementation, and maintenance of individual sub-systems of the Pharmaceutical Quality Systems (PQS).The successful candidate will be responsible for establishing governance and oversight processes to ensure compliance with...

  • Senior Quality Assurance Manager

    4 days ago

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

    Job OverviewThe Senior Quality Assurance (QA) Analyst plays a critical role in ensuring the quality of our products. As a key member of the QA team, this individual will be responsible for reviewing and approving basic and technical documentation, drafting and reviewing internal Quality policies and procedures, performing product-related activities,...

  • Quality Assurance Specialist

    4 days ago

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

    **Job Summary:**The Quality Control Stability Coordinator II will oversee the Quality Control Testing of Stability programs, including developing schedules, overseeing testing, and generating summaries from data.This role involves implementing a Quality Control Stability Program that meets client needs for each program. The position requires frequent...