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Quality Control (QC) Engineer I
Quality Control (QC) Engineer IOtsuka ICU Medical LLC • Austin, TX, US
Quality Control (QC) Engineer I

Quality Control (QC) Engineer I

Otsuka ICU Medical LLC • Austin, TX, US
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Job Description

Position Summary

The Quality Control (QC) Engineer is primarily responsible for writing instrument and test method validations, verification protocols, and corresponding reports; coordination of validation activities; implementation of standard test methods to comply with compendial changes, method transfers, cleaning validation, and improved methodology due to new technology or processes. Incumbent will interface with other departments, attend plant meetings, review and develop documents including SOP's, specifications, material testing records and prepare standard test method redlines and associated validation / document change control to ensure compliance and perform other essential duties as required.

The QC Engineer is also responsible for investigating and writing investigation documents for compliance to procedures and coordinating quality system programs and projects to ensure regulatory compliance.

The individual will demonstrate project abilities in proficiency evaluation and certification programs including knowledge of compendial (United States Pharmacopeia (USP) and European Pharmacopeia (EP or Ph. Eur.) terminology and requirements and have exhibited the ability to apply standard principles, methods, and techniques in resolving technical problems. The candidate will be highly organized, critical thinking, energetic individual that has knowledge of global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada).

Essential Duties & Responsibilities

  • Application administrator for laboratory electronic data management systems which includes management of the data, configurations of the systems, validations, corrections, and training.
  • Draft and execute laboratory equipment validations, maintenance, periodic reviews, and serve as administrator for the systems.
  • Draft and execute laboratory test method validations, transfers / verifications, and periodic reviews.
  • Executes projects relating to the QC laboratories.
  • Perform data trending analysis of QC laboratory test data.
  • Provide support activity during regulatory or 3rd party inspections.
  • Draft QC technical documents.
  • Prepare and manage departmental metrics.
  • Conduct investigations into process excursions, procedural exceptions and nonconforming events. Develop, implement, manage and track effectiveness of corrective action plans for investigations. Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations. Provide recommendations for action based on procedural requirements, decision flowcharts, and critical thinking.
  • Participate on committees / teams supporting GMP compliance programs.
  • Monitor GMP and regulatory compliance activities critical in a regulatory inspection. Communicate GMP violations and quality systems deficiencies to management.
  • Review, assess, and coordinate activities associated with updates to compendial testing.
  • Create, review, and revise SOPs and or test methods as applicable.
  • Review, evaluate, and compose summary reports for all data associated with APQR related to laboratory investigations, test method changes, and process data.
  • Perform data analysis, identify corrective / preventive actions, and implement process improvements with a focus on quality processes for the QC laboratories.
  • Performs quality review and approval of change control documentation related to validation or compendial updates as assigned.
  • Perform safety inspections on a scheduled frequency; identify and correct GMP issues while being expected to provide recommendations to management on corrective actions.
  • Perform other related duties as assigned or required.

Knowledge & Skills

  • Must have working knowledge of GMP and regulatory requirements.
  • Strong communication and organizational skills.
  • Ability to communicate with all levels of management.
  • Must possess strong technical writing skills.
  • Must possess strong computer skills for management of electronic data management systems as well as trending analysis.
  • Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.

    • Minimum Qualifications, Education & Experience

  • Must be at least 18 years of age.
  • Bachelor's degree in engineering is or related field (STEM) from an accredited college or university is required.
  • Previous pharma experience, preferred.
  • Experience in a cleanroom environment, project management, and / or quality engineering principles is desirable.
  • 0-2 years of experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above.

    • Work Environment

  • Primarily works in both the laboratory and office environment.
  • While working in the laboratory environment, there are areas where radiological hazards or lasers may be encountered and / or areas where chemical / biological hazards may be encountered.
  • Typically requires travel 5-20% 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 austinhr@icumed.com. 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

    Seniority level

    Seniority level

    Entry level

    Employment type

    Employment type

    Full-time

    Job function

    Job function

    Quality Assurance

    Industries

    Medical Equipment Manufacturing

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