Quality Control - Stability Coordinator II

Summary: The QC Stability Coordinator II 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 II 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 and compile the stability testing and 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 8 stability protocols
• 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:

• Extensive knowledge of stability testing protocols methodologies and regulatory requirements
• Understanding of ICH guidelines for stability testing
• Understanding of Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• 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:

• Bachelors degree in chemistry Biochemistry Biology Biotechnology Microbiology or similar education and minimum of 2 years experience between coordinator/management position and 1 year in a GxP setting; OR
• Masters degree and minimum of 1 year experience between coordinator/management position and 1 year in a GxP setting.

Preferred Qualifications:

• PMP Certificate
• Knowledge and experience with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• Analytical background
• Client relations 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

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race color national origin sex gender identity sexual orientation religion disability protected veteran status or any other characteristic protected by applicable federal state or local law.

If an accommodation to the application process is needed please email or call.

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.