Quality Control - Stability Coordinator II

 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 execution 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 CAPA's and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

External US

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

• 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 6 years' experience between coordinator/management position and 1 year in a GxP setting; OR
• Associates degree and minimum of 4 years' experience between coordinator/management position and 1 year in a GxP setting; OR
• Bachelor's degree and minimum of 2 years' experience between coordinator/management position and 1 year in a GxP setting; OR
• Master's degree and minimum of 1 year experience between coordinator/management position and 1 year in a GxP setting.

Preferred Qualifications

• Bachelor's degree in a scientific discipline

• PMP Certificate
• Analytical background
• Client relations background

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 e-mail FDBTHR@fujifilm.com or call 979-431-3500.