QA Investigations Specialist

Otsuka ICU Medical; Austin (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Otsuka ICU Medical seeks an Investigations Specialist to review and approve nonconformances, assess impact and lead CAPA actions. You will work with QA, Operations and Regulatory to ensure timely closure of investigations and maintain regulatory compliance.

The role requires strong analytical writing, problem-solving and facilitation skills, with familiarity with FDA regulations and quality systems across global sites.

Qualifications

• Bachelor's degree in a scientific/engineering field.
• 4–6 years in Quality, Manufacturing, Engineering or R&D.
• 2+ years leading investigations for root cause and product impact.
• Experience in regulated/pharmaceutical environments.

Responsibilities

• Review and approve nonconformances and investigation reports.
• Assist in CAPA development and tracking.
• Coordinate investigations with QA, Operations, Regulatory.
• Prepare technical summary reports and data extraction.
• Ensure compliance with FDA and company policies.
• Facilitate timely closure of investigations.

Skills

FDA regulations

Root cause analysis

Investigations systems

Communication skills

Interpersonal skills

Facilitation skills

Technical writing

Word processing

Education

Bachelor's degree

Tools

Word processing

Spreadsheets

Presentation tools

Job description

Job Description Position Summary

The Investigations Specialist will review and approve nonconformance events as directed by the QA Investigations Manager. Assist with the review and approval of impact assessments, investigation, root cause determination, and identification / creation of appropriate corrective and preventative actions to mitigate potential repeat events. Assist in the tracking and trending of events and associated corrective and preventative actions (CAPAs) to assure timely closure.

Essential Duties & Responsibilities

• Assist with the development of an investigational plan for newly created events while continuing to work closely with the assigned investigator throughout the investigation to ensure appropriate root cause and CAPAs are determined.
• Facilitate and participate in the investigation teams created to determine root cause of CAPA investigation reports and laboratory investigation reports, while serving as the liaison between Quality, Operations, and Regulatory / Compliance to facilitate timely closure of investigations.
• Perform the Quality review of nonconformances and investigation reports submitted by all assigned investigation writers. 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 in order to achieve timely approval of records.
• Perform review and approval of the 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.

Knowledge & 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.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor's Degree is required: BS, Technical (Chemistry, Biology, Microbiology, or Engineering preferred)
• 4 - 6 years' experience in Quality, Manufacturing, Engineering or R&D functions or any combination.
• 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.

Work Environment

This is largely a sedentary role. This job operates in a professional office environment and routinely uses standard office equipment. Typically requires travel less than 5% of the time.

About Us

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 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.

EEO Statement: 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 [e-mail].

We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants