Senior Quality Assurance Engineer, Supplier Management

1 week ago

Holly Springs North Carolina, United States Fujifilm Full time

Overview:
Join Fujifilm Diosynth Biotechnologies, a leader in Life Science Manufacturing and CDMO, where your expertise will contribute to groundbreaking advancements in healthcare.


At FDB, we are committed to enhancing our operations and expanding our teams, seeking dedicated individuals who aspire to make a significant impact in the biopharmaceutical industry.

Be part of our mission to manufacture innovative therapies, vaccines, and gene treatments in collaboration with pioneering biopharma companies worldwide.

We take pride in fostering a vibrant culture that ignites your passion and energy—what we refer to as Genki.

As we invest over $2 billion to establish a large-scale biopharmaceutical manufacturing site in the United States, we are set to become the largest end-to-end cell culture CDMO provider in North America. This facility will provide comprehensive solutions for clients aiming to produce biopharmaceuticals in the U.S., including drug substance manufacturing, automated fill-finish, assembly, packaging, and labeling services.



About This Role:

The Senior Quality Assurance Engineer, Supplier Management, is responsible for overseeing supplier quality to ensure that all services and materials provided to Fujifilm Diosynth Biotechnologies meet the highest standards and comply with established requirements, including cGMP regulations. This role emphasizes supplier quality management, collaborating with suppliers to uphold their approval status.

Initially, this position will play a crucial role in developing the Supplier Quality System, which includes creating Standard Operating Procedures (SOPs), Quality Agreements, Risk Assessments, Supplier Audits, and Supplier Change Notifications.

Effective collaboration, influence, and coordination with suppliers and team members across Supply Chain, Quality Control, and Quality Management are essential for success in this role.

Key Responsibilities:

  • Conduct and report on audits of GMP service providers and suppliers of various GMP materials, ensuring compliance with quality standards.
  • Maintain an updated list of approved suppliers and service providers.
  • Develop and uphold policies, procedures, checklists, self-assessment surveys, and additional documentation for internal and supplier audit programs.
  • Monitor raw material supplier quality and engage with Supply Chain, QA, and suppliers to enhance performance.
  • Track and report on audit corrective and preventative actions during Quality Management Meetings.
  • Assist in quality management interactions with regulatory authorities globally regarding quality concerns, including field alerts and recalls.
  • Support GMP inspections and audits from regulatory bodies and partners, and aid in drafting follow-up responses.
  • Contribute to other GXP functions as needed.
  • Engage in supplier change notifications and address supplier complaints.
  • Perform additional duties as assigned.
Who You Are:


You possess a collaborative mindset and are eager to work with global peers and cross-functional teams to achieve company and departmental objectives.

You demonstrate excellent communication skills, both verbal and written. Your organizational and critical thinking abilities are exceptional, with a keen attention to detail and a commitment to maintaining quality standards. You can manage multiple tasks effectively while adhering to timelines in a GMP environment, and you understand Data Integrity and the application of relevant regulations.Basic Qualifications:

  • Bachelor's Degree in Life Sciences or Engineering with 9+ years of relevant cGMP experience OR
  • Master's Degree in Life Sciences or Engineering with 7+ years of relevant cGMP experience OR
  • PhD in Life Sciences or Engineering with 5+ years of relevant cGMP experience.
  • 5+ years of experience in a cGMP Quality role within an FDA-regulated facility.
  • Prior knowledge of the pharmaceutical industry and its regulations.
  • Proficiency in MS Office Suite.
Preferred Qualifications:

  • Experience with Smartsheet, Trackwise, MasterControl, Veeva, and/or Kneat validation software.
  • Potential for occasional domestic and international travel.
  • Experience in conducting internal audits.
  • ISO 9001 Auditor Certification.
  • ASQ Certified Quality Auditor.

WORKING ENVIRONMENT

PHYSICAL DEMANDS:
Ability to stand and sit for extended periods, and perform tasks involving repetitive motions with hands and fingers.

Fujifilm Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

  • Senior Quality Engineer, Supplier Management

    5 days ago

    Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Senior Quality Engineer, Supplier Management, plays a critical role in ensuring that suppliers of services or materials to Fujifilm Diosynth Biotechnologies meet the highest quality standards while conforming to pre-established requirements, including cGMPs.Key ResponsibilitiesPrepare, conduct, and report results of audits of GMP service...

  • Senior Supplier Quality Assurance Engineer

    2 weeks ago

    North Hollywood, United States Parker Hannifin Corporation Parker Aerospace Group Full time

    Become a Key Player as a Senior Supplier Quality Assurance Engineer at Parker Hannifin Corporation Parker Aerospace GroupPosition Overview:Parker Hannifin Corporation Parker Aerospace Group stands at the forefront of innovation in the aerospace sector, specializing in the research, design, integration, production, certification, and ongoing support of...

  • Lead Quality Assurance Engineer for Suppliers

    2 weeks ago

    Colorado Springs, Colorado, United States Butler America Full time

    Position Title: Lead Quality Assurance Engineer for Suppliers Location: Fairfield, CA Compensation: $50-58 per hour Contract Duration: 6 months Overview: Butler America is seeking a Lead Quality Assurance Engineer for Suppliers to join our dynamic Propulsion division. This pivotal role involves providing quality assurance support for the manufacturing of...

  • Lead Quality Assurance Engineer for Suppliers

    2 weeks ago

    Colorado Springs, Colorado, United States Butler America Full time

    Lead Quality Assurance Engineer for SuppliersLocation: Fairfield, CA Job ID: #69600 Pay Range: $50-58 Duration: 6 mos We are seeking a Lead Quality Assurance Engineer for Suppliers to join our Propulsion division based in Fairfield, CA. This pivotal role involves delivering supplier quality oversight for both the production of engineered components and...

  • Quality Assurance Senior Engineer, DSM Disposition

    1 day ago

    Holly Springs, North Carolina, United States Fujifilm Full time

    About This RoleThe Quality Assurance Senior Engineer, DSM Disposition, is a critical position responsible for establishing and maintaining a robust and efficient disposition program at our manufacturing site.This role ensures the quality and compliance of product disposition and identifies opportunities for continuous improvement. The successful candidate...

  • Sr. Engineer, Supplier Quality

    3 weeks ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Overview: Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at FDB has never been more importantand 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...

  • Principal Supplier Quality Engineer

    2 weeks ago

    Colorado Springs, Colorado, United States Butler America Full time

    Senior Supplier Quality EngineerLocation: Fairfield, CAJob ID: #69600Pay Range: $50-58Duration: 6 mosWe are seeking a Senior Supplier Quality Engineer to join our Propulsion division. This role is pivotal in delivering quality assurance for both the production of engineered components and the procurement of commodity materials.The ideal candidate will have a...

  • Senior Quality Assurance Engineer

    1 week ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Position OverviewExplore an opportunity at a leading Life Science Manufacturing Facility & CDMOThe contributions we make at FUJIFILM Corporation are crucial, and we are in search of skilled professionals to enhance our team. Our expansion includes new locations, enhanced capabilities, and a commitment to fostering a passionate workforce dedicated to making a...

  • Senior Quality Assurance Engineer

    1 week ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Position OverviewEmbark on a career with a leader in Life Science Manufacturing and Contract Development and Manufacturing Organization (CDMO)The role at FUJIFILM Corporation is crucial in ensuring the quality and compliance of our biopharmaceutical manufacturing processes. We are expanding our capabilities and seeking dedicated professionals who are...

  • Supplier Quality Engineer

    4 weeks ago

    North Haven, United States Intellectt Inc Full time

    Role: Supplier Quality EngineerLocation: North Haven, CT - OnsiteDescription: Actively participate in product development cycle by reviewing project documentation, participating in product risk assessments, and working closely with the Product Development Team to develop appropriate verification and validation testing requirements. Assesses overall product...

  • Supplier Quality Engineer

    3 weeks ago

    North Haven, United States Intellectt Inc Full time

    Role: Supplier Quality EngineerLocation: North Haven, CT - OnsiteDescription: Actively participate in product development cycle by reviewing project documentation, participating in product risk assessments, and working closely with the Product Development Team to develop appropriate verification and validation testing requirements. Assesses overall product...

  • Supplier Quality Engineer

    4 weeks ago

    North Haven, United States Intellectt Inc Full time

    Job Title - Supplier Quality EngineerLocation - North Haven, CT (Onsite)Visa - Any valid work visa'- Lead, support, review, and approve supplier change requests, Validation, MSA, SCAPA, TMV, PPAP, Risk Assessment etc.- Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Holly Springs, United States FUJIFILM Corporation Full time

    Position OverviewEmbrace Your Passion at FUJIFILM CorporationThe role we offer is crucial in the realm of biopharmaceutical manufacturing, and we are in search of skilled professionals to enhance our team. As we expand our facilities and capabilities, we invite dedicated individuals who are committed to making a significant impact in the industry.About the...

  • Lead Supplier Quality Engineer

    2 weeks ago

    Colorado Springs, Colorado, United States Butler America Full time

    Senior Supplier Quality EngineerLocation: Fairfield, CAJob ID: #69600Pay Range: $50-58Duration: 6 mosOverview:We are seeking a dedicated Senior Supplier Quality Engineer to join our Propulsion division. This role involves providing comprehensive supplier quality oversight for the production of engineered components and commodity materials.The ideal candidate...

  • Quality Assurance Manager

    1 week ago

    Conover, North Carolina, United States Our Home Full time

    Job SummaryThis position will oversee and manage Quality, Food Safety, and Sanitation programs and activities to ensure compliance with company policies, food safety standards, government regulations, and industry best practices, including GMP and HACCP.Key ResponsibilitiesQuality Assurance: Develop and implement quality assurance policies and procedures to...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Colorado Springs, Colorado, United States Leidos Full time

    Leidos is in search of a skilled Senior Quality Assurance Engineer to become a vital part of our team. In this role, you will contribute to the development of innovative solutions for intricate challenges.As a key player within the project team, your responsibilities will encompass engineering tasks related to the design and production of hypersonic...

  • Quality Assurance Mechanical Engineer

    1 week ago

    Concord, North Carolina, United States Legrand North America Full time

    Position Overview:At a GlanceLegrand North America is seeking a Mechanical Engineer specializing in Quality Assurance to become a vital part of our Electrical Wiring Systems Pass and Seymour Team. The ideal candidate will engage in ongoing enhancement initiatives, providing support to suppliers, customers, and internal departments such as Manufacturing,...

  • Manager, Supplier Quality Assurance

    1 month ago

    North Billerica, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Quality Assurance Engineer

    2 weeks ago

    North East, Pennsylvania, United States Electric Materials Co Full time

    Job OverviewElectric Materials Co is expanding its Quality Assurance TeamPosition Summary: The Quality Engineer is tasked with supervising quality assurance processes within the manufacturing or production setting. This role includes the establishment of quality control protocols, assisting with testing and inspections, diagnosing production, process, or...

  • Quality Assurance Engineer

    23 hours ago

    Sandy Springs, GA, USA, United States Stryker Full time

    About the RoleStryker is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our products and processes.Key ResponsibilitiesSupport quality issues impacting daily operations and advocate for initiatives to enhance quality performance.Own identified...