Quality Control Project Coordinator I

Summary:

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

The Quality Control Coordinator, 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 Analyst’s and QC Management to navigate GMP documents through the EQMS system. Close attention to detail is required to update the Master Schedule on a daily basis 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. Communicating gaps and schedule changes to QC Area Managers.

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.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

Essential Functions:

• Construct and maintain a QC Master Schedule
• Assists in preparing QC metrics on a monthly basis
• Alignment of QC Master Schedule to projected manufacturing and stability schedules
• Assist in generating SOW’s and PO’s 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.
• Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish timelines
• 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.

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:

• 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:

• High school or GED and minimum of 4 years between coordinator/management position and GxP experience
• Associates degree and minimum of 2 years total between coordinator/management position or GxP experience
• Bachelor’s degree and minimum of 1 year combined between coordinator/management position and GxP experience (or equivalent)
• Master’s degree

Preferred Qualifications:

• Degree in a scientific discipline
• GMP/GLP experience
• PMP Certificate