Specialist II, Investigations

Resilience•West Chester, OH

3d•$60,000 - $90,000

About The Position

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 As a Specialist II, Lead Investigator will conduct organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation.

Requirements

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.

Nice To Haves

Bachelor’s degree preferred, 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

Responsibilities

Authors reports that document the investigation of issues including definition, scope, 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
Prioritizes work to aid in timely decisions and completion of investigations.
Escalates issues as appropriate.
Completes other duties as assigned.
Collaborates with a cross functional team to determine: Investigation strategy including a clear and actionable problem statement. Investigation action plan and timing. Root cause. CAPA action plan and effectiveness checks if required