Job Description
Position Summary
Responsible for conducting internal audit and inspection assignments as defined by audit schedule. Contributor in assessing the overall compliance status of the Austin and Round Rock facilities’ Quality Systems and Sub-Systems as well as supporting the overall success of hosted inspections. Supports the overall inspection activities in the Austin facility. When serving as the lead auditor, provide mentorship capacity to other members of the audit team as needed. This individual will function as a compliance resource.
Essential Duties & Responsibilities
- Coordinate, execute, and perform auditor/lead audit functions during internal cGMP audits to assure compliance with applicable regulations and international laws and standards, guidelines, and procedures. Develop, implement, manage, and track effectiveness of corrective action plans for non-compliant issues, and provide management with regular updates.
- Revise, review, and approve standard operating procedure change controls. Review and approve all plant SOPs, batch records and specifications for compliance to regulations, policies and procedures.
- Perform key compliance projects including gap assessments to ensure compliance with regulatory requirements, including FDA, Health Canada, and other international audits as assigned.
- Support compliance projects to achieve plant quality objectives and initiatives. Includes participation and contributions to committees/teams that support cGMP compliance programs.
- Prepare for regulatory audits and participate in external audits. Assist in staffing and training audit support personnel. Track corrective action plans including the responses to observations, person responsible and target date(s) for completion.
- Perform on-floor spot audits as required.
- Ensure Audit Plan approvals are received, and Audit Responses completed within required time frames.
- Perform other related duties as assigned or required.
Knowledge & Skills
- A working knowledge of Quality tools, including statistical analysis.
- Must possess and demonstrate the skill and ability to problem solve and critically think in order to understand connections between facts and resolutions.
- Must have the ability to evaluate situations with an analytical view.
- Working knowledge of current Good Manufacturing Practices and Good Documentation Practices.
- Must have strong time management and organizational skills.
- Successful candidate must possess the ability to communicate with all levels of management and must possess the ability to work with and/or lead a cross functional team to perform audits and convey results in an effective manner to site management.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university is required: Quality Assurance, Regulatory Affairs, Engineering, other Scientific discipline.
- Minimum of two (2) years’ experience in a cGMP environment with at least one year serving in a Pharmaceutical or GxP regulated environment, Engineering, Validation principles, Pharmaceutical manufacturing methods, Quality Systems, Analytical or microbiological testing principles.
Work Environment
- Works in a variety of areas including office, manufacturing areas, utility areas, and laboratory areas with associated conditions and hazards (including radio frequency).
- Must be able to wear all required area safety equipment and clean room garments for extended periods of time.
- Must be able to walk and stand for extended periods of time while performing audits.
- Must be able to work extended periods of time in manufacturing areas where Radio Frequency occurs.
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
