**Position Overview** The QC Investigator/CAPA Specialist 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. **Company Overview** 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. **Job Description** **Reports to** QC Compliance Officer **Work Location** College Station, TX **Primary Responsibilities:** + Leadership + 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 incidents. + 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 (CAPA) agreement with stakeholders. + New Business Growth + Support client due diligence and Quality audits as well as regulatory inspections. + Compliance + 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 1+ years of related experience. + Bachelor’s degree with3+ years of related experience; OR + 3+ years of cGMP experience. + Degree in Chemistry, Engineering, Forensics, Biology or a related life sciences discipline preferred. + Experience with data integrity as applied to quality control labs preferred. + Kepner-Tregoe Methods (5 Analytical Techniques SA, PA, DA, PPA, POA). + MEEPS. + Applied Human and Operational Performance (HOP). + 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 Trackwise, Microsoft Excel, Word and PowerPoint. + 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 as needed. + 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 **EEO Information** 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. **ADA Information** 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). **Job Locations** _US-TX-College Station_ **Posted Date** _2 days ago_ _(5/5/2025 10:22 AM)_ **_Requisition ID_** _2025-34380_ **_Category_** _Quality Control_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_