Senior Specialist II, Lead Investigator

Resilience•West Chester, OH

12d•$90,000 - $123,750

About The Position

The Senior Specialist II, Lead Investigator leads the site’s most complex and cross-functional investigations, determining the resources and strategy needed to bring each event to conclusion while considering timelines, other functional areas, and customers. Working independently in ambiguous, high-impact situations, the Lead Investigator ensures investigation outcomes and root cause analyses are completed in a timely, effective, and compliant manner. The role applies prior experience to develop solutions for novel problems and influence stakeholders across the business. The speed and rigor of the work help foster a culture that prevents deviations through a robust, proactive investigation process. Work is performed in a combination of office, laboratory, and cGMP manufacturing environments. The expected schedule is eight hours, Monday through Friday. The company may modify schedules and require overtime based on business needs. Work authorization sponsorship, including visas, is not available for this position.

Requirements

Experience in pharmaceutical manufacturing or another similar regulated industry.
Familiarity with cGMP documentation practices and applicable regulatory requirements.
Ability to assess and assimilate technical data quickly, conduct thorough investigations, and present findings, conclusions, and complex information clearly, concisely, and logically.
Ability to manage multiple concurrent investigations, monitor progress against objectives and timelines, and drive timely closure.
Excellent written, verbal, and presentation skills, including technical and investigation report writing.
Ability to work in a fast-paced, rapidly changing environment.
Ability to prioritize work activities to meet customer needs and deadlines.
Accountability, strong follow-up and follow-through, and ownership of issues throughout the investigation cycle.
Ability to exercise independent judgment with minimal direction, coach others, and build cross-functional alignment on root-cause and corrective-action decisions.

Nice To Haves

Bachelor’s degree, preferably in Science, Engineering, Regulatory, or another relevant discipline; relevant work experience may be considered in lieu of a degree.
Seven or more years of experience in pharmaceutical or other regulated manufacturing, including quality investigations and deviation management.
Understanding of internal core business processes.
Ability to identify and understand critical factors to generate appropriate solutions.
Experience across multiple sites or functions.
Familiarity with Lean problem-solving tools.

Responsibilities

Lead complex, high-impact investigations with a defined scope, strategy, and timeline; determine cross-functional resource needs and document status and progress.
Author reports documenting issue definition, scope, product impact, root cause, and corrective actions to prevent recurrence.
Use appropriate investigation tools to guide teams to root cause.
Prioritize work, support timely decisions and investigation completion, and escalate issues as appropriate.
Mentor and coach investigators on investigation methodology and report quality, and oversee their work to support speed and rigor across concurrent investigations.
Identify systemic and recurring issues and partner with functional leaders to design and implement improvements to investigation and deviation processes.
Seek and leverage internal and external skills and technical expertise to improve investigation speed and rigor.
Collaborate with cross-functional teams to establish communication strategy, a clear problem statement, investigation tools and action plan, timing, root cause, CAPA action plan, and effectiveness checks.