FUJIFILM Corporation
Senior Compliance Specialist, Manufacturing
FUJIFILM Corporation, College Station, Texas, United States, 77840
Overview:
The work we do at FDB 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, mission-driven 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 FDB 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 small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile 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.Summary
:
The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion. Support all internal and external audits. Work collaboratively with cross functional groups including Quality Assurance to support on-time release and disposition of batches and other post-execution activities.External US: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.??ComplianceLead deviation, CAPA, and change control closure for ManufacturingLeads review of quality events and initiation of new deviations, as requiredLead initiation of New Product Introduction change controlsLead Root Cause Analysis InvestigationsLead Problem Analysis (PA) eventsLead After Action Reviews (AAR)Lead the completion of Periodic ReviewsLead Internal and External Audit readiness, coordination, and response.Support Compliance Coordinators with the coordination of batch and formulation record review and corrections to executed recordsSupport Compliance Coordinators with continuous improvement of batch related documentationSupports coordination of deviation workload within the Manufacturing Compliance Coordination groupSupport the generation and maintenance of metrics around batch closure, including deviation, CAPA and change control statusSupport Compliance Coordinators to aid 100% on-time closure of all quality related investigationsProvides training and support to the Compliance CoordinatorsProvides training and support to the Deviation CoordinatorsDeviation InvestigationParticipate 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 CoordinationIs 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 productsExcellent oral and written communication skills, interpersonal and organizational skillsExcellent organizational, analytical, data review and report writing skillsThorough understanding of all aspects related to cGMP manufacturingThorough understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream)Thorough understanding of closure requirements associated to working in a Ballroom manufacturing facilityProficient user of deviation management systems such as TrackWiseProficient user of quality document control systems such as MasterControlProficient with Microsoft Office applicationsGood self-discipline and attention to detailMust 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 requiredAbility to multitask and easily prioritize workAbility to work independently with little supervisionMust have good planning skills and must be willing to interface colleagues across all levels of the FDB networkWorking 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 stretchingUse hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipmentLift up to 25 pounds frequently and up to 50 pounds, on occasionAttendance is mandatoryQualifications:Bachelors Degree and five (5) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; ORAssociate degree and seven (7) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role ;ORHigh 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 processesExperience leading teamsJoin us! FDB is advancing tomorrows 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.
The work we do at FDB 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, mission-driven 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 FDB 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 small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile 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.Summary
:
The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion. Support all internal and external audits. Work collaboratively with cross functional groups including Quality Assurance to support on-time release and disposition of batches and other post-execution activities.External US: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.??ComplianceLead deviation, CAPA, and change control closure for ManufacturingLeads review of quality events and initiation of new deviations, as requiredLead initiation of New Product Introduction change controlsLead Root Cause Analysis InvestigationsLead Problem Analysis (PA) eventsLead After Action Reviews (AAR)Lead the completion of Periodic ReviewsLead Internal and External Audit readiness, coordination, and response.Support Compliance Coordinators with the coordination of batch and formulation record review and corrections to executed recordsSupport Compliance Coordinators with continuous improvement of batch related documentationSupports coordination of deviation workload within the Manufacturing Compliance Coordination groupSupport the generation and maintenance of metrics around batch closure, including deviation, CAPA and change control statusSupport Compliance Coordinators to aid 100% on-time closure of all quality related investigationsProvides training and support to the Compliance CoordinatorsProvides training and support to the Deviation CoordinatorsDeviation InvestigationParticipate 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 CoordinationIs 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 productsExcellent oral and written communication skills, interpersonal and organizational skillsExcellent organizational, analytical, data review and report writing skillsThorough understanding of all aspects related to cGMP manufacturingThorough understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream)Thorough understanding of closure requirements associated to working in a Ballroom manufacturing facilityProficient user of deviation management systems such as TrackWiseProficient user of quality document control systems such as MasterControlProficient with Microsoft Office applicationsGood self-discipline and attention to detailMust 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 requiredAbility to multitask and easily prioritize workAbility to work independently with little supervisionMust have good planning skills and must be willing to interface colleagues across all levels of the FDB networkWorking 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 stretchingUse hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipmentLift up to 25 pounds frequently and up to 50 pounds, on occasionAttendance is mandatoryQualifications:Bachelors Degree and five (5) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; ORAssociate degree and seven (7) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role ;ORHigh 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 processesExperience leading teamsJoin us! FDB is advancing tomorrows 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.