Cardinal Health QA Microbiologist in Lewis Center, Ohio
Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines
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.
- Providing general oversight and testing for the microorganism identification program for all PET manufacturing sites, NPHS Pharmacies, and the other Cardinal health business units.
- Provides general oversight and testing for the microbiology media program for all PET manufacturing sites, NPHS Pharmacies, and the Innovation Center.
- Schedules microbial testing with third party vendor, review results and release supply for production use.
- Provides support for Environmental trending program.
- Back up for review of microbiological related NCR's (non-conformance report) and OOS' (out of specification)
- Assures the task are performed in a timely and effective manner and that all errors and failures to meet requirements are appropriately investigated and corrected.
- Ensures that all procedures related to microbiology media program are current as per guidance’s and followed as written.
- Responsible for all microbiology / sterility assurance functions including but not limited to: environmental monitoring activities, Microbiology media program document review and approval, review and execute the microbiology protocols and summary reports and microbiology / sterility assurance records management.
- Provides training as necessary for in the completion of documents and processes including but not limited to aseptic processes, environmental monitoring, sterility testing, media fills and microbiology / sterility assurance investigations.
- Interacts with and provides support to purchasing for microbiology media management
- Interacts with regulatory agencies, as necessary.
- Performs instrument IOPQ as required
- Schedules house flora studies with all PET manufacturing sites, collect data and draft reports
- Provides back up for identification laboratory for testing and review.
- May travel as needed for projects
- Bachelor's in science related field (Microbiology strongly preferred), or equivalent work experience, preferred
- 4+ years experience in related field, preferred
- 1-3 years of experience for microbial testing strongly preferred.
- Knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and aseptic practices preferred.
- Up to 10% travel
- Excellent interpersonal, organizational and communication skills.
- Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)
- Proactively develops and maintains technical knowledge in specialized area(s), remaining up to date on current trends and best practices.
What is expected of you and others at this level
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
- May contribute to the development of policies and procedures
- Works on complex projects of large scope
- Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
- Completes work independently receives general guidance on new projects
- Work reviewed for purpose of meeting objectives
- May act as a mentor to less experienced colleagues
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
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.
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