Cardinal Health
Manager, Microbiology
At a glance
Location: US-OH-Dublin Map
Posted: 02/16/2020
Closing: 03/15/2020
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Cardinal Health
Job description

Responsibilities

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.

Accountabilities

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.

Required Qualifications

  • 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.

Required Competencies

  • 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.

Manager, Microbiology