The Investigator is responsible for maximizing organizational learning and improvement from Quality deviations and Safety deviations as needed. The incumbent applies systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation assigned. The Investigator applies appropriate methodology for each 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 alert actions, and lower risk deviations The Investigator will also support higher-risk investigations as required. 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 regulations and presents investigative findings during audits as requested.
- Leads investigations for Quality deviations and incidents.
- Conducts Quality 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.
- Documents investigation reports and findings in designated Quality systems. 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.
- Participates in site deviation/CAPA management forums related to investigation status updates, metrics and escalation items.
- Presents investigations during internal and external audits.
- B.S. degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline.
- Minimum of 5 years of experience in a lab and operations environment (industrial/plant experience preferred)
- Responsible for assigned internal Quality investigations at the CLIENT’S manufacturing sites.
- Applies systematic and analytical methods to conduct investigations
- Documents investigation findings and related actions in alignment with Quality Management System requirements and governing safety regulations.
- Collaborates cross-functionally to ensure robust investigation conclusions, effective communication, and sharing of learnings
- Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
- Effective facilitation skills.
- 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. 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, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
- Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy.
- Strong oral and written communication skills.
- Demonstrated ability to analyze, extrapolate data, synthesize and determiCollects and analyzes data to evaluate operations and processes and to facilitate complex decision-making.
- Follows established modeling and evaluation methodologies to determine the effectiveness of current operational activities, isolate problem areas and develop solutions.
- Tests and validates models and results. Prepares reports that outline and rank proposed solutions and present a range of possible alternatives.
- **This position is partly remote. Candidate will need to go on site about 2-3 days a week.