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QC Project Coordinator III
QC Project Coordinator IIIFUJIFILM • College Station, TX, US
QC Project Coordinator III

QC Project Coordinator III

FUJIFILM • College Station, TX, US
4 days ago
Job type
  • Full-time
Job description

Quality Control Project Coordinator III

The Quality Control Project Coordinator III will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities.

The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing. The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities. The coordinator will assist the QC Analysts and QC Management to navigate GMP documents through the EQMS system. Close attention to detail is required to update the Master Schedule daily to ensure QC deadlines and milestones are met. Other responsibilities may include but are not limited to : compiling data for Batch Disposition, attending planning meetings as needed, and communicating gaps and schedule changes to QC Area Managers.

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

Job Description

Reports to QC Project Coordinator Supervisor, QC Manager, or Director of QC

Work Location College Station, TX

Essential Functions :

  • Follow Standard Operating Procedures (SOP's), other related Good Laboratory Practices (GLP) / Good Manufacturing Practices (GMP), and other site procedure documents (such as Chemical Hygiene Plan, SDS sheets).
  • Construct and maintain a QC Master Schedule.
  • Assists in preparing QC metrics monthly.
  • Alignment of QC Master Schedule to projected manufacturing schedules.
  • Assist in generating POs for external testing.
  • Work directly with Contract laboratories to coordinate and monitor testing per timelines.
  • Work directly with customers to update and confirm schedules and deadlines.
  • Attend daily briefings and update as needed.
  • Lead team and department meetings.
  • Assist QC Director and QC Managers to oversee and coordinate departmental training.
  • Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish timelines.
  • Work with customer and other appropriate parties to establish GMP documents.
  • Provide technical suggestions to customers based on industry guidelines.
  • Follow all established laboratory, regulatory, safety, and environmental procedures.
  • Perform other duties as assigned.

Required Skills & Abilities :

  • Must be highly organized, driven, and possess the skills and capability to plan ahead and stay on schedule.
  • Ability to evolve and adapt to new technologies to include electronic planning tools and Laboratory Information Management Systems (LIMS)
  • Computer skills in Microsoft Office and Microsoft Project
  • Ability to multi-task and prioritize work assignments with little supervision.
  • Excellent attention to detail.
  • Ability to work in a team or independent setting and collaborate with employees from various departments.
  • Excellent analytical and planning skills.
  • Must have excellent organizational, written and oral communication skills.
  • Role model for company core values of trust, delighting our customers, and Gemba.
  • Working Conditions & Physical Requirements :

  • Experience prolonged standing, some bending, stooping, and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Ability to sit for long periods to work on a computer.
  • Attendance is mandatory.
  • Minimum Qualifications :

  • Master's degree and 1+ year in GxP setting and with a combined total of 2 years between coordinator / management position and GxP experience (or equivalent).
  • Bachelor's degree and 2+ years in GxP setting with a combined total of 4 years between coordinator / management position and GxP experience (or equivalent).
  • Associates degree and 2+ years in GxP setting and a total of 6 years between coordinator / management position and GxP experience (or equivalent).
  • High school or GED and 2+ years in GxP setting and a total of 8 years between coordinator / management position and GxP experience (or equivalent).
  • Preferred Qualifications :

  • Degree in a scientific discipline.
  • GMP / GLP experience.
  • PMP Certificate.
  • Analytical background.
  • Client relations background, and / or Customer interaction training.
  • Salary : Starting salary will be commensurate with education and experience.

    To all agencies : Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email, the internet or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

    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).

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    Project Coordinator • College Station, TX, US

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