QO Investigations Coordinator 503B
Empower Pharmacy - Houston, TX
Hiring: QO Investigations Coordinator 503B Company: Empower Pharmacy Location: Houston, TX Job Posted Time: 2026-09-10 15:13:10 Target Skills & Keywords : Microsoft Excel, Quality Assurance, Root Cause Analysis, Workday About the job Required Skills: •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. •Investigation Support •Data Collection: Collect and organize investigation data for deviations, non-conformances, and laboratory or production events to support accurate, evidence-based assessments. •Initial Assessment: Conduct initial event assessments using approved templates and guidance, documenting relevant facts, observations, and potential contributing factors clearly. •Investigation Writing: Draft investigation documentation that accurately summarizes evidence, analysis, conclusions, and follow-up requirements in accordance with established procedures. •CAPA Tracking: Track corrective and preventive action commitments, due dates, and follow-up activities to support timely, complete implementation across responsible functions. •Record Maintenance: Maintain complete investigation records and supporting documentation, ensuring information remains organized, traceable, current, and aligned with procedural requirements. •Compliance Support: Apply cGMP and applicable USP , USP , and USP requirements when documenting investigations and coordinating quality follow-up activities. Qualifications: •Minimum of two years of Quality Assurance or Quality Control experience within a pharmaceutical or healthcare environment, including investigation or documentation exposure. •Associate degree in a scientific or technical discipline, or an equivalent combination of education and regulated manufacturing or health science experience. •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. •Certified Quality Improvement Associate (CQIA) preferred. •Customer Focus: Builds trust through customer-centric solutions. •Strategic AI: Guides responsible AI adoption and adaptation. •Optimizes Work Processes: Drives efficiency with continuous improvement. •Collaborates: Partners effectively to achieve shared goals. •Resourcefulness: Secures and deploys resources efficiently. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!