Quality Control - Stability Coordinator Supervisor

 The QC Stability Coordinator Supervisor, 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 Stability Supervisor, 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
• Provide technical suggestions to customers based on industry guidelines
• Lead team and department meetings
• Assist QC Director and QC Managers to oversee and coordinate departmental training
• Conduct training for new team members and periodic training for existing team members
• Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish timelines, understand upcoming QC workload, improve quality, increase efficiency, solve problems, and provide product support
• Interface with current and potential clients as well as interface with investigators during internal and external inspections
• Open and track necessary change controls
• Performs deviation management
• Perform contract reviews
• Interface with current and potential clients as well as interface with investigators during internal and external inspections.
• Supervise and lead the QC Coordinator Staff, including hiring, coaching, mentoring, and performing annual review assessments.
• Open and track necessary change controls
• 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
• Ability to identify and improve processes
• Ability to oversee employees, delegate roles and responsibilities appropriately, and provide support where needed
• Ability to provide and receive constructive feedback
• Possess excellent customer service and interaction 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 in GxP setting and a total of 12 years between coordinator/management position and GxP experience
• Associates degree and minimum of 4 years in GxP setting and a total of 10 years between coordinator/management position or GxP experience
• Bachelor's degree and minimum of 4 years in GxP setting with a combined total of 8 years between coordinator/management position and GxP experience
• Master's degree and minimum of 4 years in GxP setting and with a combined total of 6 years between coordinator/management position and GxP experience
• Experience in a lead or equivalent role
• Customer interaction training

Preferred Qualifications

• Bachelor's degree in a scientific discipline
• PMP Certificate
• Analytical background
• Client relations background
• Lean Six Sigma training or similar process improvement training

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.

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