Senior QC Deviations Investigator/CAPA Specialist

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 importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven 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 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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 highrisk 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 selfaudits 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:

• Masters Degree with 3 years of related experience; OR
• Bachelors 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.
• KepnerTregoe 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 crossfunctional 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 handeye 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.
• Onsite 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 viaemail 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.

*LIOnsite

Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or (979)).