Essential Functions:
Responsible for the following activities within the Manufacturing Support Services function:
- Work collaboratively with staff and management of site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
Compliance
- Lead deviation, CAPA, and change control closure for Manufacturing
- Leads review of quality events and initiation of new deviations, as required
- Lead initiation of New Product Introduction change controls
- Lead Root Cause Analysis Investigations
- Lead Problem Analysis (PA) events
- Lead After Action Reviews (AAR)
- Lead the completion of Periodic Reviews
- Lead Internal and External Audit readiness, coordination, and response.
- Support Compliance Coordinators with the coordination of batch and formulation record review and corrections to executed records
- Support Compliance Coordinators with continuous improvement of batch related documentation
- Supports coordination of deviation workload within the Manufacturing Compliance Coordination group
- Support the generation and maintenance of metrics around batch closure, including deviation, CAPA and change control status
- Support Compliance Coordinators to aid 100% on-time closure of all quality related investigations
- Provides training and support to the Compliance Coordinators
- Provides training and support to the Deviation Coordinators
Deviation Investigation
- Participate and support investigations for deviations and events.
- Participate in investigations and assist in identification of root and/or contributing causes.
- Ensures required Management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
- Support client due diligence and Quality audits as well as regulatory inspections.
- Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Equipment Compliance Coordination
- Is the Primary Point of Contact for any equipment related servicing and or Out of Service requests.
- Ensures all equipment is scheduled for routine maintenance and calibration and provide metrics for executed work.
- Work directly with the Facilities group to plan and support any on-site vendor support/maintenance activities including escorting on-site visitor requirements ensuring all visitors are registered for proper access on the equipment.
- Ensure all equipment utilized on the floor for manufacturing execution is entered correctly into the Building Management System and has accurate and effective preventative maintenance activities.
- Point of contact for client and regulatory inspection support with trends and metrics for all manufacturing equipment with respect to maintenance and life-cycle.
- Maintains the schedule for planned down-time for all manufacturing equipment and provides metrics for equipment up/down time.
- Leads the facility shutdown planning and associated change controls with respect to manufacturing equipment and facilities and provides metrics for all facility related change controls.
- Leads the Production Floor GEMBA walks to identify any issues/problems that need addressing to remain in compliance and provides metrics for common themes and any trends that may occur.
- Ensures routine walk throughs of the facility are completed and work orders for items found have been submitted. Also provides metrics for items found to identify and trends that may occur.
- All other duties as assigned.
Required Skills & Abilities:
- Must have a working knowledge of cGMP regulations associated to production of biologic drug products
- Excellent oral and written communication skills, interpersonal and organizational skills
- Excellent organizational, analytical, data review and report writing skills
- Thorough understanding of all aspects related to cGMP manufacturing
- Thorough understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream)
- Thorough understanding of closure requirements associated to working in a ‘Ballroom’ manufacturing facility
- Proficient user of deviation management systems such as TrackWise
- Proficient user of quality document control systems such as MasterControl
- Proficient with Microsoft Office applications
- Good self-discipline and attention to detail
- Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required
- Ability to multitask and easily prioritize work
- Ability to work independently with little supervision
- Must have good planning skills and must be willing to interface colleagues across all levels of the FDB network
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, pushing, pulling, reaching above shoulders and stretching
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion
- Attendance is mandatory
Qualifications:
- Bachelor’s Degree and five (5) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
- Associate degree and seven (7) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role ;OR
- High School Diploma or GED and nine (9) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.
Preferred Qualifications:
- Experience with cell culture and purification processes
- Experience leading teams
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
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 979-431-3500.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.