Senior Specialist, Lead Investigator

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.

Investigation Management & Execution

• 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.

• 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.

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 tools.

  • Investigation action plan and timing.

  • Root cause.

  • CAPA action plan and effectiveness checks.

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 investigations with minimal direction; coaches others and builds cross-functional alignment on root cause and corrective-action decisions.

Preferred Qualifications

• Bachelors degree, preferably in Science, Engineering, or other related technical discipline. 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 of the internal core business processes.

• Adept at identifying and understanding the critical factors in order to generate appropriate solutions.

• Multiple site or function experience

• Familiar with Lean problem-solving tools

• Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.

• This position may also include the following conditions: sitting, standing, walking, repetitive motion, and / or wearing personal protective equipment.

• May require specific visual skills such as interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors

Schedule: 8 hours - Monday- Friday
The work schedule listed reflects the employees expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including requiring overtime, 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.

Sponsorship or support for work authorization, including visas, is not available for this position.

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 candidates 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.