Compliance Investigator

Otsuka ICU Medical•Austin, TX

About The Position

The Compliance Investigator investigates and writes exception documents for compliance to procedures and coordinates quality system programs and projects to ensure regulatory compliance. The Investigator will coordinate, develop, track and manage investigations per procedures. The investigator will also assure all exception documentation adequately address root cause, corrective & preventive actions and product impact.

Requirements

Must have working knowledge of Good Manufacturing Practices and regulatory requirements.
Strong communication and organizational skills.
Ability to communicate with all levels of management.
Must possess strong technical writing skills to document investigation findings.
Problem solving will be addressed in two specific ways: People and Processes.
In the area of people, he/she must be able to foster a participative approach to problem solving. Must also be able to build an atmosphere of trust, open communication, and respect in order to handle the difficult issues in investigations and corrective action follow up.
In the area of processes, he/she will be required to utilize technical expertise to identify and understand problems that may elevate to serious compliance issues.
Bachelor’s Degree is required: Engineering, Science, or Manufacturing (other 4yr degrees considered with commensurate experience)
Minimum of 2 years’ experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above.
Must be at least 18 years of age

Nice To Haves

CQA or CQE preferred
Preferred experience in one or more of the following areas: Validation principles; Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical or microbiological testing principles.
Experience in project management and quality engineering principles preferred.

Responsibilities

Conduct investigations into process excursions, procedural exceptions and nonconforming events.
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.