Cardinal Health P29545 - Senior Specialist, Quality Assurance in El Paso, Texas
What Quality Assurance contributes to Cardinal Health
Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.
- Demonstrates knowledge of quality systems and approaches.
- Demonstrates an understanding of the relevant regulations, standards and operating procedures.
- Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
- Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
- Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
- Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
- Assist in scheduling laboratory and sterility release activities
- Assist in reviewing test data to ensure testing documentation is thorough and free of errors and that all results are provided to customers in a timely manner
- Assist in reviewing and revising internal SOPs to maintain regulatory compliance
- Participates in and supports EO and dose audit testing, such as bioburden and product sterility testing for assigned groups
- Ensure continual employee compliance with internal SOPs and applicable standards
- Participate in extensive departmental cross-training activities
- Bachelors degree in scientific field, Biology or Microbiology strongly preferred, or equivalent work experience.
- 3-5 years’ experience in a quality role that involved writing SOP's, test methods, etc required
- Laboratory bench work experience highly desired
- Previous sterility assurance experience highly desired.
What is expected of you and others at this level
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possbile solutions to a variety of technical problems and takes actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.