Senior Specialist, Lead Investigator Position Available In Chester, Pennsylvania

Job Description:

A career at Resilience is more than just a job – it’s anopportunity to change the future. Resilience is atechnology-focused biomanufacturing company that’s changing the waymedicine is made. We’re building a sustainable network ofhigh-tech, end-to-end manufacturing solutions to better withstanddisruptive events, serve scientific discovery, and reach those inneed. For more information, please visit www.resilience.com

Position Summary:

The Senior Specialist, Lead Investigator isresponsible for performing investigations and driving each event toconclusion by working with others. The Lead Investigator ensuresthe investigation outcome and root cause analysis are completed ina timely, effective, and compliant manner. The speed and rigordemonstrated by the Lead Investigator will drive a culture thatprevents unplanned deviations through a robust and proactiveinvestigation process. This is a site-based position in WestChester, OH.

Position Responsibilities:

Conducts organizedinvestigations with a well-defined scope, strategy, and timelinedocumenting status and progress of the investigation. Authorsreports that document the investigation of issues includingdefinition, scope, product impact, root cause, and correctiveactions to prevent the recurrence of the issue. Seeks and leveragesthe skills and technical expertise of internal and externalresources to improve the speed and rigor of investigations.

Collaborates with a cross functional team to determine:

Communication strategy so all stakeholders have appropriateinformation. Investigation strategy including a clear andactionable problem statement. Investigation tools. Investigationaction plan and timing. Root cause. Solution selection. CAPA actionplan and effectiveness checks. Utilizes the appropriate andapproved investigation tools necessary to drive the team to rootcause. Prioritizes work to aid in timely decisions and completionof investigations. Escalates issues as appropriate. Completes otherduties as assigned.

Minimum Qualifications:

Experience inPharmaceutical Manufacturing and/or other similar regulatedindustry. Ability to quickly assess and assimilate technical dataand conduct a thorough investigation; ability to present findings,conclusions, and complex information in a clear, concise, andlogical manner. Excellent written, verbal, and presentation skills.

Ability to monitor activities to accomplish stated objectives in aneffective manner. Ability to work in a fast-paced and rapidlychanging environment. Ability to prioritize work activities to meetcustomer needs and deadlines. Ability to take accountability withexcellent follow up and follow through; owns issues through thefull cycle investigation process.

Preferred Qualifications:

Bachelor’s degree required, preferably in Science, Engineering, orother related technical discipline. Relevant work experience willbe considered in lieu of a degree. Understanding of the internalcore business process including relevant cGMP and regulatory. Adeptat identifying and understanding the critical factors in order togenerate appropriate solutions. Multiple site or functionexperience Experience with Quality Management Deviations. Strongtechnical writing skills. Familiar with Lean problem solving tools.

Proficiency with Microsoft Office Suite and have a workingknowledge, or the ability to learn, computer systems such asTrackWise, SAP, LIMS, and Electronic Batch Record Systems. Thisposition may also include the following conditions: Sitting,standing, walking, repetitive motion, monitoring other people’swork, wear personal protective equipment, and frequent use of acomputer. The items described here are representative of those thatmust be met successfully to perform the essential functions of thisjob. Resilience is an Equal Employment Opportunity Employer.

Qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex, sexual orientation,gender perception or identity, national origin, age, maritalstatus, protected veteran status, disability status, physical ormental disability, genetic information, or characteristic, or othernon-job-related characteristics or other prohibited groundsspecified in applicable federal, state, and local laws. Requestsfor reasonable accommodation can be made at any stage of therecruitment process. Resilience offers employees a robust totalrewards program including equity, an annual cash bonus program, a401(k) plan with a generous company match and our benefits packagewhich is thoughtfully designed to support our employees with greathealthcare (including medical, dental and vision), family buildingbenefits, life and disability insurance, flexible time off, paidholidays, other paid leaves of absence, tuition reimbursement andsupport for caregiving needs. Our target base pay hiring range forthis position is $80,000.00 – $117,500.00 per year. Actual base payis dependent upon a number of factors, including but not limitedto, the candidate’s geographical location, relevant experience,qualifications, skills and knowledge. Excited about Resilience andthe biomanufacturing revolution? We encourage you to apply andstart a conversation with one of our recruiters.