Job Description
Compliance Investigator - Manufacturing Investigations & Lab Investigations
This position is 100% onsite in Austin TX
FLSA Status: Exempt
Position Summary
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.
Essential Duties & 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.
Knowledge, Skills & Qualifications
- 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.
Education And Experience
- 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.
- 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.
Minimum Qualifications
- Must be at least 18 years of age
- Must pass pre-employment drug screen and background check
Travel Requirements
- Typically requires travel less than 5% of the time
Physical Requirements And Work Environment
- General office conditions with occasional entry to laboratories, warehouse, manufacturing, and clean-room manufacturing spaces.
- Occasional lifting of sample boxes is required.
- Must be able to lift up to 25 lbs. unassisted.
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and 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 identity, gender expression, gender reassignment, 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 humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
OFCCP Equal Opportunity Posters
“Know Your Rights” Poster
Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants
