Quality Control - Stability Coordinator I

Summary:

The QC Stability Coordinator I will construct maintain and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates overseeing testing of each pull and generating summaries from the data.

The Quality Control Coordinator I under general direction will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry Cell Biology Microbiology and Quality Assurance groups to coordinate of testing deviation management and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee scheduling the stability testing and compiling data to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPAs and deviations client meetings attending planning meetings communication of changes and utilizing new software.

The work we do at FUJIFILM Diosynth Biotechnologies 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 missiondriven people like you who want to make a real difference in peoples 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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.

Essential Functions:

Assists in preparing QC metrics on a monthly basis

Performing pulls occur within the specified window

Ensuring testing occurs within the specified window

Assist in generating POs for external testing

Work directly with Contract laboratories to coordinate and monitor testing and release schedules

Work directly with customers to update and confirm schedules and deadlines

Attend daily briefings and update as needed

Assist QC Director and QC Managers

Ability to work cross functionally with other Quality Control groups Quality Assurance Manufacturing and Project Management to establish timelines

Establish GMP documentation

Review GMP documentation

Update GMP documentation

Follow all established laboratory regulatory safety and environmental procedures

Maintain and execute a minimum of 6 stability protocols

Performs deviation management

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 multitask 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

Minimum Qualifications:

High school or GED and minimum of 4 years in GxP setting or coordinator/management position

Associates degree and minimum of 2 years in GxP setting or coordinator/management position

Bachelors degree and minimum of 1 year in GxP setting or coordinator/management position

Masters degree and no minimum GxP coordinator/management experience

Preferred Qualifications:

Bachelors degree in a scientific discipline

PMP Certificate

Previous coordinator or management experience

Analytical Background

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 handeye 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

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.