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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
Brief Job Description
The Senior Specialist, LeadInvestigatoris responsible forperforming investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis are completed ina timely, effective, and compliant manner. The speed and rigordemonstratedby the Lead Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.
Job Responsibilities
Investigation Management & Execution
Conducts organized investigations with a well-defined scope, strategy, and timeline, documentingstatusand progress of the investigation.
Authorsreportsthat document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
Utilizes theappropriateand approved investigation tools necessary to drive the team to root cause.
Prioritizes work to aid intimelydecisions and completion of investigations. Escalates issues asappropriate.
Root Cause & Cross-Functional Collaboration
Seeksandleveragesthe skills and technicalexpertiseof internal and external resources to improve the speed and rigor of investigations.
Collaborates with a cross-functional team todetermine:
Communication strategy so all stakeholders haveappropriate information.
Investigation strategyincludinga clear and actionable problem statement.
Investigation tools.
Investigation action plan and timing.
Root cause.
Solutionselection.
CAPA action plan and effectiveness checks.
MinimumQualifications
Experience in Pharmaceutical Manufacturing and/or other similar regulatedindustry.
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,monitoringprogress againstobjectivesand timelines to drivetimelyclosure.
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 excellentfollow upand follow through;ownsissues through the full cycle investigation process.
Exercises independent judgment to advance investigations with minimal direction; coaches others and builds cross-functional alignment on root cause and corrective-action decisions.
PreferredQualifications
Bachelor's degree, preferably in Science, Engineering, or other related technicaldiscipline. Relevant work experience will be considered in lieu of a degree.
5+ years of experience in a pharmaceutical or other regulated manufacturing environment, including quality investigations and deviation management.
Understanding ofthe internal core business processes.
Adept atidentifyingand understanding the critical factorsin order togenerateappropriate solutions.
Multiple site or function experience
Familiar with Lean problem-solving tools
Physical & Work Environment
Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.
Work Schedule: 8 hours - Monday- Friday
The work schedule listed reflects the employee's expected schedule at the time ofhire. The Company reserves the right tomodifywork schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This position may also include the following conditions: sitting, standing, walking, repetitive motion, and / or wearing personal protective equipment. The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Sponsorship or support for work authorization, including visas, is not available for this position.
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.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $117,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.