JOB PURPOSE:
The Investigator is responsible for maximizing organizational learning and improvement from Quality and Safety deviations.
The incumbent applies systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation assigned.
The Investigator identifies the best methodology for the given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence.
Assigned investigations include cross site deviations and safety events of both low and high risk.
The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence.
The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines.
The incumbent ensures investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested.
MAIN ACCOUNTABILITIES:
1. Leads investigations for Quality and Safety deviations and incidents. Conducts Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. May support complex and/or high impact investigations. Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
2. Documents investigation reports and findings in designated Quality and Safety systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
3. Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
4. Presents investigations during internal and external audits.
A minimum of 5 years of experience with Master’s; 8 years of experience with Bachelor’s; 12 years of experience with A.S., with that experience in a lab and operations environment (industrial/plant experience preferred)
• Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
• Strong facilitation skills and proven record to effectively lead cross-functional teams.
• Strong 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.
• Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles.
• Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
• Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems..