**_What Sterility Assurance contributes to Cardinal Health_**
This position reports into Sterility Assurance and is responsible for the support and management of site level Sterility Assurance programs such as Environmental Monitoring, Bioburden Monitoring and/or Gamma Quarterly Dose Audit (QDA) program monitoring.
Responsible for coordination and oversight of off-site testing related to the site Environmental Monitoring, Bioburden and/or Dose Audit Programs.
**_ Accountabilities_**
- Conduct and interpret Environmental Monitoring testing
- Conduct laboratory investigations
- Manage inventory control for laboratory supplies
- Participate in the coordination of the laboratory activities
- Provide support in the validation, maintenance and cleaning of laboratory equipment and laboratory
- Collection and submission of samples per the established sampling schedule for bioburden and /or Dose audit process as required, or any other sample required
- Responsible for Data trending and maintenance of the site EM and bioburden/QDA programs, including the sample pull schedule for the site.
- Execute Alert and Action Limit calculations according to CAH procedures and applicable ISO standards for all programs
- Authoring and maintenance of procedure, policy, and form updates within quality system
- Generate trending metrics for EM and bioburden/QDA programs
- Work cross-functionally with internal microbiology labs and other site departments to support Change Development Processes (CDPs)
**_ Qualifications_**
- Bachelor's degree completed in microbiology, biotechnology, chemistry, biology or related field preferred or equivalent industry experience.
- Minimum 1 years working in Microbiology area (preferred)
- Medical devices industry experience (preferred)
- Knowledge related to the microbiology area
- Knowledge in Aseptic Technique
- Knowledge in Microsoft Office package
- General knowledge of industry regulations pertaining to GMPs, GDPs and GLPs
- LIMS knowledge (preferred)
- English level: intermediate
- Knowledge in data management
**_ What is expected of you and others at this level_**
- Attention to detail.
- Ability to work with cross-functional teams
- Adheres to established policies and procedures
- Ability to work proactively and independently.
- Ability to multi-task and efficient in time management.
- Excellent verbal communication and interpersonal skills
- 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._