What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
Job Summary
Provides overall direction and management of the microbiology / sterility assurance function that supports all Positron Emission Tomography (PET) manufacturing sites Nuclear Health & Precision Safety (NPHS) Pharmacies, and the Innovation Center.
Responsibilities
Responsible for all microbiology / sterility assurance functions including but not limited to: environmental monitoring activities, microbiology / sterility assurance document review and approval, product disposition related to microbiological issues, investigation and remediation of microbiology / sterility assurance issues, review and approval of microbiology protocols and summary reports and microbiology / sterility assurance records management.
Provides advice, guidance and training 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.
Establishes and implements procedures related to microbiology / sterility assurance.
Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures related to microbiology / sterility assurance.
Interacts with regulatory agencies, as necessary.
Designing and managing specialized microbiological studies and protocols.
Ensuring that all Environmental Monitoring is performed and trended according to procedure. Identify trending and provide guidance for corrective actions.
Ensuring the review of microbiological related Nonconformance's (NCRs) and Out of Specification's (OOSs) are performed in a timely and effective manner and that all errors and failures to meet requirements are appropriately investigated and corrected.
Ensuring that all procedures related to microbiology and sterility assurance are current as per guidance's and followed as written.
Qualifications
B.S. in a science related field, microbiology preferred, or equivalent work experience, preferred.
3-5 years of experience in an FDA regulated industry in a microbiological capacity preferred.
Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirements.
Excellent interpersonal, organizational and communication skills.
Demonstrated leadership and the ability to motivate others preferred.
Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.) preferred.
Ability to travel 25%-50%.
Location
Remote, work from home
Ability to travel 25%-50%.
What is expected of you and others at this level
Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
Participates in the development of policies and procedures to achieve specific goals
Recommends new practices, processes, metrics, or models
Works on or may lead complex projects of large scope
Projects may have significant and long-term impact
Provides solutions which may set precedent
Independently determines method for completion of new projects
Receives guidance on overall project objectives
Acts as a mentor to less experienced colleagues
Anticipated salary range: $102,000-$145,700
Bonus eligible: Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
#LI-Remote
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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.
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges – now, and in the future.As a global, growing company, we’re able to offer rewarding careers that let you make a positive impact on our customers and communities.
