Compliance Investigator

Otsuka ICU Medical•Austin, TX

1d•Hybrid

About The Position

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.

Requirements

Bachelor’s degree (or foreign equivalent) in Industrial Engineering, Manufacturing Engineering, or closely related field plus two (2) years of experience in Quality, Manufacturing, Engineering, R&D Functions, job offered, or closely related occupation.
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered.
Expertise/knowledge may be gained through employment experience or education.
Required expertise/knowledge includes: Experience with Manufacturing principles including one or more of the following: Good Manufacturing Practices (GMP), Technical writing, and Quality Management System (QMS) business process experience
Experience with problem solving using Root Cause Analysis tools
Experience with regulatory requirements including 21 CFR part 11, 210 & 211
Experience effectively communicating with all levels of management through writing and/or presentation
Experience recommending continuous improvement plans where necessary using the Six Sigma and/or DMAIC methodologies
Experience fostering a participative approach to problem-solving by conducting cross-functional team meetings and presenting significant events to leadership for input
Experience with corrective action follow up utilizing technical expertise and negotiation skills to bridge the gaps between Quality and Manufacturing requirements.

Responsibilities

Conduct investigations into process excursions, procedural exceptions and nonconforming events that contribute to the root cause of customer complaints.
Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations.
Synthesize recommendations for action based on procedural requirements, decision flowcharts, and critical thinking.
Document investigations results.
Develop, implement, manage and track effectiveness of corrective action plans for exceptions.
Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes as required.
Manage projects to ensure they are completed within the required time schedule as required per quality systems.
Provide support activity during regulatory or 3rd party audits.
Prepare departmental metrics.
Utilize trend data to develop schedule and incorporate into facility investigations.
Ensure accurate project schedules are maintained and communicated to management.
Write field alert report and prepare and deliver notifications to management.
Participate on committees/teams supporting GMP compliance programs.
Adhere to all company guidelines, SOPs and ensure required compliance training is up to date.
Monitor GMP and regulatory compliance activities critical in a regulatory inspection.
Communicate GMP violations and quality systems deficiencies to management and recommend MQ product release holds until the violation is addressed.
Perform other related duties as assigned or required.