Quality Investigator

Empower Pharmacy•Houston, TX

14h

About The Position

The Quality Investigator provides dedicated ownership of complex nonconformance investigations at Empower’s 503A site within a highly regulated 503A/503B organization. This individual contributor gathers evidence, conducts root cause analysis, and writes clear, consistent investigation reports to 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. It requires sound judgment, disciplined execution, and the ability to translate complex technical information into defensible conclusions without compromising product quality or patient safety. The Quality Investigator identifies recurring issues, strengthens investigation documentation, adapts to evolving procedures and priorities, and helps build sustainable internal capability and reliable operations as demand and organizational complexity grow.

Requirements

At least 3 years of experience in quality assurance or quality control, including independently writing complex investigations, conducting root cause analysis, and supporting corrective actions.
Bachelor’s degree in science or a related field, or an equivalent combination of relevant education and practical investigation experience.
Demonstrated success managing concurrent investigations, meeting documentation deadlines, and coordinating technical input from multiple stakeholders in a regulated operating environment.
Proficiency in technical writing and Microsoft Word and Excel.
Working knowledge of root cause analysis and corrective and preventive action methods, including 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.

Nice To Haves

Experience supporting pharmaceutical or compounding investigations.
Experience improving investigation documentation and reducing or preventing backlogs through consistent follow-through and process improvement.

Responsibilities

Gather and evaluate relevant records and stakeholder input to establish event timelines, investigation scope, and documented facts.
Analyze complex nonconformances, distinguish contributing factors from root causes, and substantiate conclusions with evidence.
Draft complete, technically accurate investigation reports connecting nonconformance details, supporting evidence, root causes, and proposed corrective actions.
Manage assigned investigations through documentation and review, resolve reviewer comments, and coordinate outstanding inputs to support timely closure.
Track investigation aging, prioritize work by risk and due dates, and escalate barriers before unresolved cases accumulate.
Partner with process owners to develop corrective and preventive actions that address documented root causes and help prevent recurrence.
Apply site procedures and applicable USP requirements to investigation documentation, and promptly escalate product quality or patient safety concerns.
Present investigation findings to Quality and operational stakeholders, explain supporting rationale, and resolve technical questions.
Identify recurring investigation and documentation issues, recommend process improvements, and share practical writing guidance to strengthen internal investigation capability.