Senior Specialist II, Lead Investigator

Summary

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Senior Specialist II, Lead Investigator leads the site's most complex and cross-functional investigations, determining the resources and strategy needed to drive each event to conclusion in consideration of timelines, other functional areas, and customers. Operating independently in ambiguous, high-impact situations, the Lead Investigator ensures investigation outcomes and root cause analyses are completed in a timely, effective, and compliant manner, applying prior experience to facilitate development of solutions for novel problems and influencing stakeholders across the business. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents deviations through a robust and proactive investigation process. Job Responsibilities Investigation Management & Execution - Leads complex, high-impact investigations with a well-defined scope, strategy, and timeline, determining the resources needed across functional areas and documenting status and progress throughout. - Authors reports that document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue. - Utilizes the appropriate investigation tools necessary to drive the team to root cause. - Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate. - Mentors and coaches other investigators on investigation methodology and report quality, and oversees their work to ensure speed and rigor across concurrent investigations. - Identifies systemic and recurring issues across investigations and partners with functional leaders to design and implement improvements to the investigation and deviation processes. Root Cause & Cross-Functional Collaboration - Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations. - Collaborates with a cross-functional team to determine: - Communication strategy so all stakeholders have appropriate information. - Investigation strategy including a clear and actionable problem statement. - Investigation tool(s) to use. - Investigation action plan and timing. - Root cause. - CAPA action plan and effectiveness checks. Experience & Education Minimum Qualifications Experience in Pharmaceutical Manufacturing and/or other similar regulated industry. Familiarity with cGMP documentation practices and applicable regulatory requirements. Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner. Ability to manage multiple concurrent investigations, monitoring progress against objectives and timelines to drive timely closure. Excellent written, verbal, and presentation skills, including technical and investigation report writing. Ability to work in a fast-paced and rapidly changing environment. Ability to prioritize work activities to meet customer needs and deadlines. Ability to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process. Exercises independent judgment to advance investi

Job Description

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Senior Specialist II, Lead Investigator leads the site's most complex and cross-functional investigations, determining the resources and strategy needed to drive each event to conclusion in consideration of timelines, other functional areas, and customers. Operating independently in ambiguous, high-impact situations, the Lead Investigator ensures investigation outcomes and root cause analyses are completed in a timely, effective, and compliant manner, applying prior experience to facilitate development of solutions for novel problems and influencing stakeholders across the business. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents deviations through a robust and proactive investigation process. Job Responsibilities Investigation Management & Execution - Leads complex, high-impact investigations with a well-defined scope, strategy, and timeline, determining the resources needed across functional areas and documenting status and progress throughout. - Authors reports that document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue. - Utilizes the appropriate investigation tools necessary to drive the team to root cause. - Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate. - Mentors and coaches other investigators on investigation methodology and report quality, and oversees their work to ensure speed and rigor across concurrent investigations. - Identifies systemic and recurring issues across investigations and partners with functional leaders to design and implement improvements to the investigation and deviation processes. Root Cause & Cross-Functional Collaboration - Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations. - Collaborates with a cross-functional team to determine: - Communication strategy so all stakeholders have appropriate information. - Investigation strategy including a clear and actionable problem statement. - Investigation tool(s) to use. - Investigation action plan and timing. - Root cause. - CAPA action plan and effectiveness checks. Experience & Education Minimum Qualifications Experience in Pharmaceutical Manufacturing and/or other similar regulated industry. Familiarity with cGMP documentation practices and applicable regulatory requirements. Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner. Ability to manage multiple concurrent investigations, monitoring progress against objectives and timelines to drive timely closure. Excellent written, verbal, and presentation skills, including technical and investigation report writing. Ability to work in a fast-paced and rapidly changing environment. Ability to prioritize work activities to meet customer needs and deadlines. Ability to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process. Exercises independent judgment to advance investi