The Senior QC Deviation Investigator/CAPA Specialist is responsible for leading 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. Skills and experience must include high level complex investigations that may require global stakeholder engagement.

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Reports to                Associate Director, QC Compliance

Work Location         College Station, TX 

Primary Responsibilities:

• Leadership
• Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Lead investigations for critical, high-risk Quality deviations and incidents. Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing regulations. 
• Lead complex and/or high impact investigations, including those with product impact. Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
• Assist in develop of staff in investigative techniques and mentor Investigators. Provides training on various roles related to investigations as required.
• Provide metrics to Senior Leadership.
• Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
• Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
• New Business Growth
• Support client due diligence and Quality audits as well as regulatory inspections.
• Presents investigations during internal and external audits. Conducts internal self-audits of investigations and identified continuous improvement actions.
• Compliance
• Developing, maintaining and driving continuous improvements while providing quality oversight of the GxP training program which includes:
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

Qualifications:

• Master’s Degree with 3+ years of related experience; OR
• Bachelor’s degree with 5+ years of related experience.
• 5+ years of cGMP experience.
• Degree in Chemistry, Biology, Engineering, Forensics or a related life sciences discipline preferred.
• Experience with data integrity as related to quality control labs preferred.
• Kepner-Tregoe Methods (5 Analytical Techniques SA, PA, DA, PPA, POA)
• MEEPS
• Applied Human and Operational Performance (HOP) preferred.
• Experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
• 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.
• Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
• Experience in performance improvement with basis in Human and Organizational Performance principles.  
• Practical knowledge and application of cGMP, cGLP, EMEA, compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
• Ability to set personal performance goals and provide input to departmental objectives.
• Proficient in Microsoft Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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.
• On-site attendance is required.

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.

*LI-Onsite

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).