Compliance Investigator
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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. *Work from home permitted. When not working from home must report to Austin TX office. *< 5% domestic travel required per year.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Bachelors 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.
SPECIAL REQUIREMENTS:
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. Such expertise/knowledge cannot be quantified by time. 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.
Otsuka ICU Medical LLC is an equal opportunity employer.
To apply forOtsuka ICU Medical LLCs Compliance Investigatorposition please send resume to: humanresouces@
Must reference JOB CODE:TX1224HA
Key Skills
- Epidemiology
- Public Health
- Bank Secrecy Act
- Bioinformatics
- Fraud
- Genetics
- Interviewing
- Law Enforcement
- Qualitative Research Interviewing
- Research Experience
- Next Generation Sequencing
- Writing Skills
About Company
Innovation, Impact, and Purpose. Find Your Future Here. 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 ... View more
