QO Investigations Coordinator 503B

Empower Pharmacy•Houston, TX

10d•Onsite

About The Position

The QO Investigations Coordinator supports product integrity and compliant quality operations by coordinating investigation activities, maintaining accurate records, and advancing timely resolution of quality events. Working within Empower’s hyper-growth, highly regulated 503A and 503B environment, this role supports investigations involving deviations, non-conformances, and laboratory or production events while aligning documentation with USP standards, cGMP requirements, and established procedures. The coordinator gathers and analyzes data, assists with root cause analysis, tracks corrective and preventive actions, and prepares metrics that highlight recurring issues and improvement opportunities. Success requires disciplined execution, sound judgment, strong organization, clear communication, and learning agility. The role contributes directly to investigation quality, documentation accuracy, CAPA follow-through, operational visibility, continuous improvement, and strong execution consistency while helping protect product quality, patient safety, and regulatory readiness across daily quality operations.

Requirements

Working knowledge of quality investigation practices, including data collection, event documentation, root cause support, CAPA tracking, and investigation record maintenance.
Understanding of cGMP requirements and USP <795>, USP <797>, and USP <800> standards as applied to quality documentation and investigation activities.
Strong analytical, organizational, and time management skills for compiling accurate data, tracking follow-up actions, and managing multiple investigation priorities.
Proficiency with Microsoft Excel and Word, plus the ability to navigate investigation tracking systems and prepare clear, accurate quality reports.
Minimum of two years of Quality Assurance or Quality Control experience within a pharmaceutical or healthcare environment, including investigation or documentation exposure.
Demonstrated ability to collect, analyze, and document quality data accurately while following established procedures and supporting investigation timelines.
Strong written communication, attention to detail, organization, and cross-functional coordination skills in a regulated, documentation-driven work environment.

Nice To Haves

Associate degree in a scientific or technical discipline, or an equivalent combination of education and regulated manufacturing or health science experience.
Experience supporting deviations, non-conformances, CAPAs, trending reports, or investigation tracking within pharmaceutical manufacturing or another regulated quality setting preferred.
Certified Quality Improvement Associate (CQIA) preferred.

Responsibilities

Collect and organize investigation data for deviations, non-conformances, and laboratory or production events to support accurate, evidence-based assessments.
Conduct initial event assessments using approved templates and guidance, documenting relevant facts, observations, and potential contributing factors clearly.
Draft investigation documentation that accurately summarizes evidence, analysis, conclusions, and follow-up requirements in accordance with established procedures.
Track corrective and preventive action commitments, due dates, and follow-up activities to support timely, complete implementation across responsible functions.
Maintain complete investigation records and supporting documentation, ensuring information remains organized, traceable, current, and aligned with procedural requirements.
Apply cGMP and applicable USP <795>, USP <797>, and USP <800> requirements when documenting investigations and coordinating quality follow-up activities.
Collaborate with Quality leadership and cross-functional partners to gather information, resolve documentation gaps, and advance investigations toward timely closure.
Compile investigation metrics and trending reports that identify recurring issues, emerging patterns, and practical opportunities for continuous improvement.
Escalate missing information, overdue actions, or investigation barriers promptly, enabling Quality leadership to address risks and maintain execution discipline.