Sr. QA Investigator Compliance
The Sr. QA Investigator 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.
- 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 (CAPA) 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.
- Developing, maintaining and driving continuous improvements while providing quality oversight
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- All other duties as assigned.
Required Skills & Abilities:
- 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.
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
- Attendance is mandatory.
- Bachelor's degree with 10+ years of related experience; OR
- Associates degree and/or 12+ years of related experience
- At least 5 years of cGMP experience.
- Degree in Engineering, 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)
- Applied Human and Operational Performance (HOP)
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 e-mail FDBTHR@fujifilm.com or call 979-431-3500.