Quality Investigator

POSITION SUMMARY:

The Quality Investigator provides dedicated ownership of complex nonconformance investigations at Empower’s 503A site within a hyper-growth, highly regulated 503A/503B organization. This individual contributor gathers evidence, conducts root cause analysis, and writes clear, consistent investigation reports that support timely closure and appropriate corrective and preventive actions. The role partners with Quality and operational stakeholders to resolve documentation gaps, maintain investigation progress, and prevent backlog recurrence. Success requires sound judgment, disciplined execution, and the ability to translate complex technical information into defensible conclusions without compromising product quality or patient safety. By identifying recurring issues, strengthening investigation documentation, and adapting to evolving procedures and priorities, the Quality Investigator builds sustainable internal capability, reduces reliance on temporary support, and helps Empower maintain reliable operations as demand and organizational complexity continue to grow.

RESPONSIBILITIES:

Investigation Execution

• Evidence Review: Gather and evaluate relevant records and stakeholder input to establish clear event timelines, investigation scope, and documented facts.
• Root Causes: Analyze complex nonconformances, distinguish contributing factors from root causes, and substantiate conclusions with evidence rather than unsupported assumptions.
• Investigation Writing: Draft complete, technically accurate investigation reports that connect nonconformance details, supporting evidence, root causes, and proposed corrective actions.

Closure and Backlog Control

• Case Ownership: Manage assigned investigations through documentation and review, resolve reviewer comments, and coordinate outstanding inputs to support timely closure.
• Backlog Prevention: Track investigation aging, prioritize work by risk and due dates, and escalate barriers before unresolved cases accumulate.
• Corrective Actions: Partner with process owners to develop corrective and preventive actions that address documented root causes and support recurrence prevention.

Quality and Collaboration

• Regulated Documentation: Apply site procedures and applicable USP requirements to investigation documentation, escalating product quality or patient safety concerns promptly.
• Stakeholder Alignment: Present investigation findings to Quality and operational stakeholders, explain supporting rationale, and resolve technical questions to support informed decisions.
• Process Improvement: Identify recurring investigation and documentation issues, recommend process improvements, and share practical writing guidance to strengthen internal investigation capability.

KNOWLEDGE AND SKILLS:

• Proficiency in technical writing and Microsoft Word and Excel to organize investigation evidence, develop clear narratives, and maintain accurate progress tracking.
• Working knowledge of root cause analysis and corrective and preventive action methods, with disciplined evaluation of evidence and contributing factors.
• Knowledge of applicable USP standards, including USP 795, 797, and 800, and site procedures governing compounding quality and investigation documentation.
• Ability to prioritize concurrent investigations, communicate technical findings across functions, resolve information gaps, and escalate risks while maintaining documentation accuracy.

EXPERIENCE AND QUALIFICATIONS: 

• 3 years of experience in quality assurance or quality control, including independently writing complex investigations, conducting root cause analysis, and supporting corrective actions required.
• Bachelor’s degree in science or a related field, or an equivalent combination of relevant education and practical investigation experience required.
• Demonstrated success managing concurrent investigations, meeting documentation deadlines, and coordinating technical input from multiple stakeholders in a regulated operating environment required.
• Experience supporting pharmaceutical or compounding investigations, improving investigation documentation, and reducing or preventing backlogs through consistent follow-through and process improvement preferred.