The Manager, Microbiology I Sterility Assurance:
- Provides overall direction and management of the microbiology / sterility assurance function that supports all PET manufacturing sites, NPHS Pharmacies, and the Innovation Center.
- Is 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.
- Monitors microbiology / sterility assurance performance measures.
- 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.
The Manager, Microbiology I Sterility Assurance is primarily responsible for:
- Providing general oversight to the microbiology I sterility assurance program for all PET manufacturing sites, NPHS Pharmacies, and the Innovation Center.
- 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 NCRs and 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.
- B.S. in a science related discipline, microbiology preferred
- 3-5 years of experience in an FDA regulated industry in a microbiological capacity.
- 3-5 years of experience in a lab I quality management role.
- 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.
- 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.
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.