QA Investigations Specialist

Otsuka ICU Medical • Austin, TX

2d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level