Senior Specialist, Lead Investigator

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

Position Summary:

The Senior Specialist, Lead Investigator is responsible for performing investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.

This is a site-based position in West Chester, OH.

Position Responsibilities:

• Conducts organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation.

• 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.

• 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 tools.

  • Investigation action plan and timing.

  • Root cause.

  • Solution selection.

  • CAPA action plan and effectiveness checks.

• Utilizes the appropriate and approved 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.

• Completes other duties as assigned.

Minimum Qualifications:

• Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.

• 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.

• Excellent written, verbal, and presentation skills.

• Ability to monitor activities to accomplish stated objectives in an effective manner.

• 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.

Preferred Qualifications:

• Bachelor's degree required, preferably in Science, Engineering, or other related technical discipline. Relevant work experience will be considered in lieu of a degree.

• Understanding of the internal core business process including relevant cGMP and regulatory. Adept at identifying and understanding the critical factors in order to generate appropriate solutions.

• Multiple site or function experience

• Experience with Quality Management Deviations.

• Strong technical writing skills.

• Familiar with Lean problem solving tools.

• Proficiency with Microsoft Office Suite and have a working knowledge, or the ability to learn, computer systems such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems.

This position may also include the following conditions:

• Sitting, standing, walking, repetitive motion, monitoring other people's work, wear personal protective equipment, and frequent use of a computer.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.