Deviation Coordinator I

Overview

The work we do at FDB has never been more important—and 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 people’s 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 Deviation Coordinator I is responsible for supporting deviation investigations to ensure accurate, thorough, and on time completion.  The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation.

Internal Job Description

Essential Functions:

• Teamwork / Collaboration
• 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
• 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
• New Business Growth
• Support client due diligence and Quality audits as well as regulatory inspections.
• Compliance
• Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• All other duties as assigned

Required Skills & Abilities:

• Facilitation skills and proven record to effectively lead cross-functional teams
• Technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear, and concise narrative
• Ability to interpret technical information and documentation used for operations and production activities
• Ability to communicate effectively across organizations
• Ability to set personal performance goals and provide input to departmental objectives
• Proficient in Microsoft Excel, Word, and PowerPoint

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
• Ability to sit for long periods to work on a computer
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position
• Lifting up to 25 pounds on occasion
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
• Must be willing to work flexible hours
• Ability to work weekends and off-shift hours, as needed to support manufacturing activities
• Must be willing to travel

Qualifications:

• Bachelor’s degree with 2 years relevant experience; OR
• Associates degree and 4 years of relevant experience; OR
• High School / GED or technical school with 6 years relevant experience, and
• At least 1 year of cGMP experience

Preferred Qualifications:

• Degree in Engineering, Sciences, Organizational Psychology, Industrial Safety, Forensics, or a related scientific discipline
• Six Sigma Black Belt
• Kepner-Tregoe Methods (5 Analytical Techniques SA, PA, DA, PPA, POA)
• Conger-Elsea Methods (HBT/DA, Logic FT, E&CF chart)
• MEEPS
• Applied Human and Operational Performance (HOP)

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.