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About the Role
The Investigations Specialist will review and approve nonconformance events, assist with impact assessments, root cause determination, and corrective/preventative actions. This role also supports tracking and trending of events to ensure timely closure.
Responsibilities
- Assist with the development of an investigational plan for newly created events.
- Work closely with the assigned investigator throughout the investigation to ensure appropriate root cause and CAPAs are determined.
- Facilitate and participate in investigation teams to determine root cause of CAPA and laboratory investigation reports.
- Serve as the liaison between Quality, Operations, and Regulatory/Compliance to facilitate timely closure of investigations.
- Perform Quality review of nonconformances and investigation reports.
- Ensure records are reviewed in a timely fashion and are supported by properly documented evidence.
- Work closely with employees at multiple levels within the organization to achieve timely approval of records.
- Perform review and approval of Quality system records (nonconformances, investigations, CAPAs, effectiveness checks, extension requests, status reports, etc.).
- Organize data, extract key information, and write technical summary reports.
- Ensure compliance with all global regulatory agencies including FDA as well as corporate policies and procedures.
- Perform other related duties as assigned or required.
Requirements
- Must be at least 18 years of age.
- Prior investigation writing experience with a minimum of 2 years leading investigations determining root cause and product impact.
- Experience in a regulated industry; Pharmaceutical preferred.
Skills
- Working knowledge of FDA regulations.
- Knowledge of various quality tools such as root cause analysis and investigations systems.
- Strong oral and written communication skills.
- Strong interpersonal skills with ability to interface with multiple levels of people in the organization, including plant personnel and management.
- Excellent facilitation/presentation skills and ability to facilitate strategy meetings.
- Superior technical writing and problem solving skills.
- Expertise with word-processing, spreadsheet, and presentation software.
Location
- Office environment
Work Type
- Sedentary role
- Office environment
- Travel less than 5% of the time
Experience Level
- 4 - 6 years' experience in Quality, Manufacturing, Engineering or R&D functions or any combination.
- Minimum of 2 years leading investigations determining root cause and product impact.
Education Level
- Bachelor's Degree is required: BS, Technical (Chemistry, Biology, Microbiology, or Engineering preferred)
About the Company
- 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.
Equal Opportunity
- Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
- We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
- If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.