Quality Control Operations Manager

 The QC Operations Support Manager will manage, maintain, and oversee the day-to-day operations of the Quality Control Project Coordinators, Sample Management, and Stability Coordinators.    

The Quality Control Operations Support Manager will oversee and manage staff in a multi-functional support role.  This position will require the QC Operational Manager to supervise QC employees staffed in the following areas:  QC Project Coordinators, Sample Management, and Stability Coordinators. The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities.  The QC Operations Manager will ensure all three operational support groups are fully informed and aligned with current and future GMP processes, to include stability studies, release testing, project scheduling, and company / departmental milestones.  Close attention to detail and good organizational skills are essential to ensure QC Operations meet department and company goals. 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.  

External US

Essential Functions:

• Work with QC Coordinators and QC Managers to ensure testing schedules are built out and adhered to in support of in-process, release, outsource and stability samples.  
• Work directly with the QC Managers and Smart QC vendor to build out and maintain the testing database.
• Provide support to QC coordinators and Project Managers to ensure client meetings are productive and ensure proper updates are provided in a timely manner.
• Prepare QC metrics on a monthly basis
• Work with Raw Materials staff to improve and provide support on raw material receipt and storage.
• Work directly with customers to update and confirm schedules and deadlines. Assist in mitigating delays in project timelines. 
• Oversee Sample Management staff to provide guidance and support as needed.
• Provide support and oversight to the Stability Coordinator staff to ensure protocols and reports are drafted and distributed in a timely manner.
• Navigate documents through the Master Control process effectively and follow up to ensure customers are updated as needed.
• Attend Tier 2 and QC Tier meetings daily and update QC Staff as needed.
• Assist QC Director and QC Managers to oversee and coordinate departmental training
• Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish and maintain project timelines
• Perform other duties as assigned.

Required Skills & Abilities:

• Knowledge and experience in business, supervision, and management.
• Knowledge of the functions, operation, and mission of the specific department.
• Demonstrated ability to lead and develop a department and department staff members.
• 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 a must-Microsoft Office and Microsoft Project
• Ability to multi-task and prioritize work assignments
• Excellent attention to detail.
• 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:

• Master's degree in Biology, Chemistry, Biochemistryor similar education/experience and 6 years' GMP experience; OR
• Bachelor's degree in Biology, Chemistry, Biochemistry or similar education/experience and 8 years' GMP experience; OR
• Associate degree in Biology, Chemistry, Biochemistry or similar education/experience and 10 years' GMP experience
• Previous supervisory experience or demonstrated skills to lead and mentor a group cohesively, effectively and with compliance

Preferred Qualifications:

• GMP/GLP experience
• PMP Certificate

Salary:  Starting salary will be commensurate with education and experience. 

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 FDBTHR@fujifilm.com or call 979-431-3528.